Trial Outcomes & Findings for Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions (NCT NCT00833937)

NCT ID: NCT00833937

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Blood samples collected over 24 hour period
• Results posted on: 2024-08-19

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	12	12
First Intervention COMPLETED	12	12
First Intervention NOT COMPLETED	0	0
Washout STARTED	12	12
Washout COMPLETED	11	12
Washout NOT COMPLETED	1	0
Second Intervention STARTED	11	12
Second Intervention COMPLETED	11	12
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

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
Washout Withdrawal by Subject	1	0

Baseline Characteristics

Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Zolpidem (Test) First n=12 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=12 Participants Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Zolpidem n=23 Participants Zolpidem Tartrate 10 mg Tablet (test) dosed in either period	Ambien® n=23 Participants Ambien® 10 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	117.313 ng/mL Standard Deviation 42.878	116.452 ng/mL Standard Deviation 40.419

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Zolpidem n=23 Participants Zolpidem Tartrate 10 mg Tablet (test) dosed in either period	Ambien® n=23 Participants Ambien® 10 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	541.580 ng*h/mL Standard Deviation 279.254	543.732 ng*h/mL Standard Deviation 273.918

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Zolpidem n=23 Participants Zolpidem Tartrate 10 mg Tablet (test) dosed in either period	Ambien® n=23 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)	530.272 ng*h/mL Standard Deviation 271.461	531.866 ng*h/mL Standard Deviation 265.350

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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