Trial Outcomes & Findings for Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects (NCT NCT01020877)
NCT ID: NCT01020877
Last Updated: 2010-06-29
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Blood samples collected over a 60 hour period.
Results posted on
2010-06-29
Participant Flow
Participant milestones
| Measure |
Test (Metronidazole) First
0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
|
Reference (MetroGel-Vaginal®) First
0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
19
|
19
|
|
First Intervention
COMPLETED
|
19
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
19
|
19
|
|
Washout of 7 Days
COMPLETED
|
19
|
19
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
19
|
19
|
|
Second Intervention
COMPLETED
|
18
|
19
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test (Metronidazole) First
0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
|
Reference (MetroGel-Vaginal®) First
0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
|
|---|---|---|
|
Second Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Test (Metronidazole) First
n=19 Participants
0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
|
Reference (MetroGel-Vaginal®) First
n=19 Participants
0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
|
Total
n=38 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
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More Than One
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Metronidazole)
n=36 Participants
0.75% Metronidazole Vaginal Gel test product dosed in either period.
|
Reference (MetroGel-Vaginal®)
n=36 Participants
0.75% MetroGel-Vaginal® reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
281.111 ng/mL
Standard Deviation 72.222
|
257.194 ng/mL
Standard Deviation 71.228
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Metronidazole)
n=36 Participants
0.75% Metronidazole Vaginal Gel test product dosed in either period.
|
Reference (MetroGel-Vaginal®)
n=36 Participants
0.75% MetroGel-Vaginal® reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
5921.046 ng*h/mL
Standard Deviation 1713.316
|
5593.855 ng*h/mL
Standard Deviation 1683.155
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Metronidazole)
n=36 Participants
0.75% Metronidazole Vaginal Gel test product dosed in either period.
|
Reference (MetroGel-Vaginal®)
n=36 Participants
0.75% MetroGel-Vaginal® reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
5989.237 ng*h/mL
Standard Deviation 1737.791
|
5693.259 ng*h/mL
Standard Deviation 1735.116
|
Adverse Events
Test (Metronidazole)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Reference (MetroGel-Vaginal®)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Metronidazole)
n=38 participants at risk
0.75% Metronidazole Vaginal Gel test product dosed in either period.
|
Reference (MetroGel-Vaginal®)
n=38 participants at risk
0.75% MetroGel-Vaginal® reference product dosed in either period.
|
|---|---|---|
|
General disorders
Headache
|
15.8%
6/38 • Number of events 7 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
21.1%
8/38 • Number of events 9 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Nausea
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.3%
2/38 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Blood in Urine
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Diarrhea
|
0.00%
0/38 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Abdominal Pain/Cramps
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
0.00%
0/38 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Protein in Urine
|
0.00%
0/38 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
Additional Information
Associate Director, Biopharmaceutics
TEVA Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER