Trial Outcomes & Findings for Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions (NCT NCT00939367)

Results Overview

The maximum or peak concentration that the drug reaches in the plasma

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.

Results posted on

2018-06-28

Participant Flow

healthy, normal subjects

Participant milestones

Participant milestones
Measure	Torrent's Zolpidem First, Then Ambien For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg. Followed by a 7 day washout period. For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg.	Ambien First, Then Torrent's Zolpidem For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg Followed by a 7 day washout period. For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg.
First Intervention STARTED	15	15
First Intervention COMPLETED	15	15
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	15	15
Second Intervention COMPLETED	15	15
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=30 Participants Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.6 years STANDARD_DEVIATION 7.48 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment India	30 participants n=5 Participants

PRIMARY outcome

Timeframe: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.

The maximum or peak concentration that the drug reaches in the plasma

Outcome measures

Outcome measures
Measure	Experimental n=30 Participants Torrent's Zolpidem Tartrate Tablets 10 mg	Active Comparator n=30 Participants Ambien® 10mg tablets
Maximum Plasma Concentration (Cmax)	130.58 ng/mL Standard Deviation 40.61	124.53 ng/mL Standard Deviation 37.48

PRIMARY outcome

Timeframe: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.

The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)

Outcome measures

Outcome measures
Measure	Experimental n=30 Participants Torrent's Zolpidem Tartrate Tablets 10 mg	Active Comparator n=30 Participants Ambien® 10mg tablets
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	734.29 ng.hr/mL Standard Deviation 416.53	705.45 ng.hr/mL Standard Deviation 356.65

PRIMARY outcome

Timeframe: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.

The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

Outcome measures

Outcome measures
Measure	Experimental n=30 Participants Torrent's Zolpidem Tartrate Tablets 10 mg	Active Comparator n=30 Participants Ambien® 10mg tablets
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)	776.65 ng.hr/mL Standard Deviation 484.20	734.01 ng.hr/mL Standard Deviation 384.90

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Active Comparator

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental n=30 participants at risk Torrent's Zolpidem Tartrate Tablets 10 mg	Active Comparator n=30 participants at risk Ambien® 10mg tablets
General disorders Regurgitation of water and food content	6.7% 2/30 • Number of events 2	3.3% 1/30
General disorders Giddiness	3.3% 1/30 • Number of events 1	3.3% 1/30

Additional Information

Kedar Joshi

Accutest Research Laboratories Pvt. Ltd.

Phone: +91 22 27780718

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER