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Trial Outcomes & Findings for Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate (NCT NCT03642873)

NCT ID: NCT03642873

Last Updated: 2019-06-20

Results Overview

Pharmacokinetic Parameter Cmax (Maximum measured plasma concentration)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Results posted on

2019-06-20

Participant Flow

This was a single-centre study.

A total of 24 subjects entered the study, among them 23 subjects completed the study.

Participant milestones

Participant milestones
Measure
Sequence ABC
First Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended Release (ER) bi-layer tablet by mouth under fasted state Second Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence ACB
First Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Second Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence BAC
First Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Third Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence BCA
First Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence CAB
First Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Third Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence CBA
First Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
First Intervention (1 Day)
STARTED
4
4
4
4
4
4
First Intervention (1 Day)
COMPLETED
4
4
4
4
4
4
First Intervention (1 Day)
NOT COMPLETED
0
0
0
0
0
0
Washout (7 Days)
STARTED
4
4
4
4
4
4
Washout (7 Days)
COMPLETED
4
4
4
4
4
4
Washout (7 Days)
NOT COMPLETED
0
0
0
0
0
0
Second Intervention (1 Day)
STARTED
4
4
4
4
4
4
Second Intervention (1 Day)
COMPLETED
4
4
4
4
4
4
Second Intervention (1 Day)
NOT COMPLETED
0
0
0
0
0
0
Third Intervention (1 Day)
STARTED
4
4
4
4
4
4
Third Intervention (1 Day)
COMPLETED
4
4
4
4
3
4
Third Intervention (1 Day)
NOT COMPLETED
0
0
0
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Sequence ABC
First Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended Release (ER) bi-layer tablet by mouth under fasted state Second Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence ACB
First Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Second Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence BAC
First Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Third Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence BCA
First Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence CAB
First Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Third Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Sequence CBA
First Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Second Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Third Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Scheduled Washout of 7 days between each doses.
Third Intervention (1 Day)
Screen failure
0
0
0
0
1
0

Baseline Characteristics

Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=24 Participants
Participants were randomized at each visit to receive either Treatment A (Reference): Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state Treatment B (Reference): Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Treatment C (Test): Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state Scheduled Washout of 7 days between each doses. All study participants received all three treatments
Age, Continuous
29.6 Years
STANDARD_DEVIATION 9.2 • n=99 Participants
Sex: Female, Male
Female
14 Participants
n=99 Participants
Sex: Female, Male
Male
10 Participants
n=99 Participants
Race/Ethnicity, Customized
American Indian
1 Participants
n=99 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=99 Participants
Race/Ethnicity, Customized
Black
2 Participants
n=99 Participants
Race/Ethnicity, Customized
Caucasian
17 Participants
n=99 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants
n=99 Participants
Weight
148.3 lb
STANDARD_DEVIATION 18.8 • n=99 Participants
Height
67.5 Inches
STANDARD_DEVIATION 3.3 • n=99 Participants
Elbow Breadth
2.6 Inches
STANDARD_DEVIATION 0.2 • n=99 Participants
Frame Size
Small
7 participants
n=99 Participants
Frame Size
Medium
15 participants
n=99 Participants
Frame Size
Large
2 participants
n=99 Participants

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Population: Pharmacokinetic (PK) Data Sets included all the 24 subjects for analysis.

Pharmacokinetic Parameter Cmax (Maximum measured plasma concentration)

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=23 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
1770 ng/mL
Standard Deviation 628
1810 ng/mL
Standard Deviation 784
11.3 ng/mL
Standard Deviation 2.14
11.3 ng/mL
Standard Deviation 1.78

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Population: Pharmacokinetic (PK) Data Sets

Pharmacokinetic Parameter AUC(0-t) The area under the plasma concentration versus time curve from time 0 to time of the last measurable concentration.

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=23 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
8286.2 ng*hr/mL
Standard Deviation 2440.0
8186.7 ng*hr/mL
Standard Deviation 2801.0
133.36 ng*hr/mL
Standard Deviation 29.407
132.99 ng*hr/mL
Standard Deviation 23.053

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Population: Pharmacokinetic (PK) Data Sets

The area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/ Kel, where Ct is the last measurable concentration.

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=20 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=21 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=23 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
8501.5 ng*hr/mL
Standard Deviation 2784.5
8347.8 ng*hr/mL
Standard Deviation 2762.4
140.44 ng*hr/mL
Standard Deviation 32.792
139.70 ng*hr/mL
Standard Deviation 26.044

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Population: Pharmacokinetic (PK) Data Sets

Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase.

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=20 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=21 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=23 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
0.205 1/hr
Standard Deviation 0.104
0.207 1/hr
Standard Deviation 0.199
0.151 1/hr
Standard Deviation 0.0251
0.155 1/hr
Standard Deviation 0.0233

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Population: Pharmacokinetic (PK) Data Sets

Pharmacokinetic Parameter (Tmax) Time of the maximum measured plasma concentration.

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=23 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
1.08 hr
Standard Deviation 0.551
1.04 hr
Standard Deviation 0.415
9.59 hr
Standard Deviation 2.16
9.33 hr
Standard Deviation 2.09

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Population: Pharmacokinetic (PK) Data Sets

Apparent first-order terminal elimination half-life was calculated as 0.693/Kel.

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=20 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=21 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=23 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Apparent Terminal Elimination Half-life (T1/2) of Guaifenesin
4.82 hr
Standard Deviation 3.30
5.34 hr
Standard Deviation 3.13
4.71 hr
Standard Deviation 0.833
4.60 hr
Standard Deviation 0.831

SECONDARY outcome

Timeframe: Upto Day 17

Population: Pharmacokinetic (PK) Data Sets

Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/ pain. Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.

Outcome measures

Outcome measures
Measure
Treatment A (Reference) - Plasma Guaifenesin
n=24 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
Treatment C (Test) - Plasma Guaifenesin
n=23 Participants
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatments B (Reference) - Plasma Hydrocodone Bitartrate
n=24 Participants
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Treatment C (Test) - Plasma Hydrocodone Bitartrate
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
Number of Adverse Events(AEs) Experienced by Participants
TEAE by severity: Mild
7 Events
12 Events
25 Events
—
Number of Adverse Events(AEs) Experienced by Participants
TEAE by severity: Moderate
0 Events
1 Events
0 Events
—
Number of Adverse Events(AEs) Experienced by Participants
TEAE by severity: Severe
0 Events
0 Events
0 Events
—
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP - Unlikely
4 Events
0 Events
1 Events
—
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP - Possible
3 Events
8 Events
8 Events
—
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP - Probable
0 Events
5 Events
16 Events
—

Adverse Events

Treatment A

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Treatment B

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Treatment C

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment A
n=24 participants at risk
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state
Treatment B
n=23 participants at risk
Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
Treatment C
n=24 participants at risk
Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
Cardiac disorders
Palpitations
0.00%
0/24 • Up to Day 17
4.3%
1/23 • Number of events 1 • Up to Day 17
0.00%
0/24 • Up to Day 17
Eye disorders
Lacrimation increased
4.2%
1/24 • Number of events 1 • Up to Day 17
0.00%
0/23 • Up to Day 17
0.00%
0/24 • Up to Day 17
Gastrointestinal disorders
Nausea
0.00%
0/24 • Up to Day 17
17.4%
4/23 • Number of events 4 • Up to Day 17
8.3%
2/24 • Number of events 2 • Up to Day 17
Gastrointestinal disorders
Stomach discomfort
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
General disorders
Fatigue
0.00%
0/24 • Up to Day 17
8.7%
2/23 • Number of events 2 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Nervous system disorders
Clumsiness
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Nervous system disorders
Dizziness
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
25.0%
6/24 • Number of events 8 • Up to Day 17
Nervous system disorders
Head discomfort
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Nervous system disorders
Headache
16.7%
4/24 • Number of events 4 • Up to Day 17
21.7%
5/23 • Number of events 5 • Up to Day 17
20.8%
5/24 • Number of events 6 • Up to Day 17
Nervous system disorders
Paraesthesia
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Nervous system disorders
Tremor
0.00%
0/24 • Up to Day 17
4.3%
1/23 • Number of events 1 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Psychiatric disorders
Euphoric mood
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
4.2%
1/24 • Number of events 1 • Up to Day 17
0.00%
0/23 • Up to Day 17
0.00%
0/24 • Up to Day 17
Respiratory, thoracic and mediastinal disorders
Sneezing
4.2%
1/24 • Number of events 1 • Up to Day 17
0.00%
0/23 • Up to Day 17
0.00%
0/24 • Up to Day 17
Vascular disorders
Pallor
0.00%
0/24 • Up to Day 17
0.00%
0/23 • Up to Day 17
4.2%
1/24 • Number of events 1 • Up to Day 17

Additional Information

Clinical Research Director, Clinical Research

Reckitt Benckiser, Inc

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place