Trial Outcomes & Findings for Two Way Bioequivalence Study Under Fed Conditions (NCT NCT01217801)
NCT ID: NCT01217801
Last Updated: 2017-05-02
Results Overview
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1 and Day 7
Results posted on
2017-05-02
Participant Flow
Healthy adult study participants between 18-45 years (inclusive) of age who were willing to participate in the study by providing written informed consent
Participant milestones
| Measure |
Ondansetron Orally Dissolving Filmstrip Then ODT
Ondansetron Orally Dissolving Filmstrip 8 mg then 7 days then Ondansetron Orally Disintegrating Tablet 8 mg measure AUC
|
Ondansetron Orally Disintegrating Tablet Then OD Film
Ondansetron Orally Disintegrating Tablet AUC Ondansetron 8 mg then 7 days then Ondansetron Orally Disintegrating Film 8 mg measure AUC
|
|---|---|---|
|
Period 1
STARTED
|
24
|
24
|
|
Period 1
COMPLETED
|
23
|
22
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
23
|
22
|
|
Period 2
COMPLETED
|
23
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ondansetron Orally Dissolving Filmstrip Then ODT
Ondansetron Orally Dissolving Filmstrip 8 mg then 7 days then Ondansetron Orally Disintegrating Tablet 8 mg measure AUC
|
Ondansetron Orally Disintegrating Tablet Then OD Film
Ondansetron Orally Disintegrating Tablet AUC Ondansetron 8 mg then 7 days then Ondansetron Orally Disintegrating Film 8 mg measure AUC
|
|---|---|---|
|
Period 1
Protocol Violation
|
1
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Two Way Bioequivalence Study Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Ondanestron Orally Dissolving Filmstrip
n=24 Participants
Ondanestron Orally Dissolving Filmstrip (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Disintegrating tablets (8 mg); AUCs for each period will be calculated.
|
Ondanestron Orally Disintegrating Tablet
n=24 Participants
Ondanestron Orally Disintegrating Tablet (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Dissolving Filmstrip (8 mg); AUCs for each period will be calculated.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
26.78 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
26.78 years
STANDARD_DEVIATION 5.8 • n=107 Participants
|
26.78 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
48 participants
n=99 Participants
|
48 participants
n=107 Participants
|
48 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 7Population: All that completed a period
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Outcome measures
| Measure |
Film
n=45 Participants
AUC film strip
|
Tablet
n=45 Participants
tablet AUC
|
|---|---|---|
|
Area Under Plasma Concentration
|
213.7 ng*hr/ml
Standard Deviation 47.8
|
225.9 ng*hr/ml
Standard Deviation 49.08
|
Adverse Events
Ondanestron Orally Dissolving Filmstrip
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ondanestron Orally Disintegrating Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ondanestron Orally Dissolving Filmstrip
n=48 participants at risk
Ondanestron Orally Dissolving Filmstrip AUC
|
Ondanestron Orally Disintegrating Tablet
n=48 participants at risk
Ondanestron Orally Disintegrating Tablet AUC
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
4.2%
2/48 • Number of events 2 • study period Plus 30 days
|
0.00%
0/48 • study period Plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
URTI
|
2.1%
1/48 • Number of events 1 • study period Plus 30 days
|
0.00%
0/48 • study period Plus 30 days
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • study period Plus 30 days
|
0.00%
0/48 • study period Plus 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place