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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 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=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 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=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 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=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

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