Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00939536
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : October 22, 2013
Last Update Posted : October 22, 2013
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: Zolpidem Tartrate Tablets 10 mg
Enrollment 24
Recruitment Details  
Pre-assignment Details healthy, normal subjects
Arm/Group Title Torrent's Zolpidem First, Then Ambien Ambien First, Then Torrent's Zolpidem
Hide Arm/Group Description

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.

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.

Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Second Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Experimental Active Comparator Total
Hide Arm/Group Description Torrent's Zolpidem Tartrate Tablets 10 mg Ambien® 10mg tablets Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
28.2  (6.7) 28.2  (6.7) 28.2  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
4
  33.3%
4
  33.3%
8
  33.3%
Male
8
  66.7%
8
  66.7%
16
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description The maximum or peak concentration that the drug reaches in the plasma
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description:
Torrent's Zolpidem Tartrate Tablets 10 mg
Ambien® 10mg tablets
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/ml
177.69  (57.05) 172.64  (72.15)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Hide Description The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description:
Torrent's Zolpidem Tartrate Tablets 10 mg
Ambien® 10mg tablets
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mcg*hr/mL
751.31  (399.17) 717.71  (401.92)
3.Primary Outcome
Title The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description:
Torrent's Zolpidem Tartrate Tablets 10 mg
Ambien® 10mg tablets
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mcg*hr/mL
778.16  (418.74) 741.65  (415.73)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description Torrent's Zolpidem Tartrate Tablets 10 mg Ambien® 10mg tablets
All-Cause Mortality
Experimental Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Active Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Active Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/24 (37.50%)      0/24 (0.00%)    
General disorders     
vomiting  4/24 (16.67%)  4 0/0  0
nausea  2/24 (8.33%)  2 0/0  0
regurgitation of water content  2/24 (8.33%)  2 0/0  0
giddiness  1/24 (4.17%)  1 0/0  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kedar Joshi
Organization: Accutest Research Laboratories Pvt. Ltd.
Phone: +91 22 27780718
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00939536     History of Changes
Other Study ID Numbers: US/05/003
First Submitted: July 13, 2009
First Posted: July 15, 2009
Results First Submitted: July 22, 2009
Results First Posted: October 22, 2013
Last Update Posted: October 22, 2013