NCT00939367

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

Completed Phase 1 Results posted Last updated 28 June 2018

What this trial tests

Phase 1 trial testing Zolpidem Tartrate Tablets 10 mg in Healthy in 50 participants. Completed in 2 May 2007.

Timeline

24 February 2007

Primary endpoint
2 May 2007

2 May 2007

Quick facts

Lead sponsor	Torrent Pharmaceuticals Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	24 February 2007
Primary completion	2 May 2007
Estimated completion	2 May 2007
Sites	1 location across India

Drugs / interventions tested

• Zolpidem Tartrate Tablets 10 mg — full drug profile →
• 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Torrent Pharmaceuticals Limited — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Plasma Concentration (Cmax) Primary · 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

Group	Value	95% CI
Experimental	130.58	± 40.61
Active Comparator	124.53	± 37.48

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Primary · 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)

Group	Value	95% CI
Experimental	734.29	± 416.53
Active Comparator	705.45	± 356.65

The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) Primary · 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.

Group	Value	95% CI
Experimental	776.65	± 484.20
Active Comparator	734.01	± 384.90

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental

Serious: 0/30 (0%)

Deaths: —

Active Comparator

Serious: 0/30 (0%)

Deaths: —

Other adverse events (2 terms — click to expand)

Reaction	System	Experimental	Active Comparator
Regurgitation of water and food content	General disorders	—	—
Giddiness	General disorders	—	—

Data from ClinicalTrials.gov NCT00939367 adverse events section.

Sponsor's own description

Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.