Trial Outcomes & Findings for Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions (NCT NCT00833521)
NCT ID: NCT00833521
Last Updated: 2024-08-21
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Blood samples collected over 24 hour period
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
Zolpidem (Test) First
Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
|
Ambien® (Reference) First
Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
19
|
19
|
|
First Intervention
COMPLETED
|
19
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
19
|
19
|
|
Second Intervention
COMPLETED
|
19
|
19
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Zolpidem (Test) First
n=19 Participants
Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
|
Ambien® (Reference) First
n=19 Participants
Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in 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
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 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 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Zolpidem
n=38 Participants
Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
|
Ambien®
n=38 Participants
Ambien® 10 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
140.868 ng/mL
Standard Deviation 38.646
|
154.703 ng/mL
Standard Deviation 42.540
|
PRIMARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Zolpidem
n=38 Participants
Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
|
Ambien®
n=38 Participants
Ambien® 10 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
506.876 ng*h/mL
Standard Deviation 239.392
|
519.319 ng*h/mL
Standard Deviation 258.098
|
PRIMARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Zolpidem
n=38 Participants
Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
|
Ambien®
n=38 Participants
Ambien® 10 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
|
497.884 ng*h/mL
Standard Deviation 228.860
|
510.833 ng*h/mL
Standard Deviation 246.619
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER