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Trial record 23 of 124 for:    ZOLPIDEM AND Central Nervous System Depressants

Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

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ClinicalTrials.gov Identifier: NCT00658541
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : January 20, 2010
Last Update Posted : May 3, 2011
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Healthy
Therapeutic Equivalency
Interventions Drug: Zolpidem Tartrate 10 mg tablet
Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets
Hide Arm/Group Description On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg. On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
Period Title: First Intervention
Started 19 19
Completed 19 19
Not Completed 0 0
Period Title: Washout Period of 7 Days
Started 19 19
Completed 18 17
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             1
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 18 17
Completed 18 17
Not Completed 0 0
Arm/Group Title Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets
Hide Arm/Group Description All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
38
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
30.21  (11.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
9
  23.7%
Male
29
  76.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  15.8%
White
31
  81.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate
Hide Description The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
Time Frame serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.
Arm/Group Title Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Hide Arm/Group Description:
Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: ng/mL
123.61  (42.45) 131.92  (45.02)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate
Hide Description The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.
Time Frame serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.
Arm/Group Title Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Hide Arm/Group Description:
Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
518.69  (194.66) 518.68  (184.35)
3.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate
Hide Description The area under the zolpidem tartrate 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 serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.
Arm/Group Title Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Hide Arm/Group Description:
Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
560.88  (234.32) 561.96  (230.63)
Time Frame 38 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 36 subjects were administered Zolpidem 10 mg Tablets and 37 subjects were administered Ambien® 10 mg Tablets.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Hide Arm/Group Description All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast. All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
All-Cause Mortality
Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/37 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem Tartrate 10 mg Tablets Ambien® 10 mg Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/36 (25.00%)      6/37 (16.22%)    
Eye disorders     
Diplopia *  2/36 (5.56%)  2 1/37 (2.70%)  1
Gastrointestinal disorders     
Vomiting *  0/36 (0.00%)  0 1/37 (2.70%)  1
Nausea *  1/36 (2.78%)  1 1/37 (2.70%)  1
Nervous system disorders     
Blurred vision *  0/36 (0.00%)  0 1/37 (2.70%)  1
Sedation *  0/36 (0.00%)  0 1/37 (2.70%)  1
Confusion *  0/36 (0.00%)  0 1/37 (2.70%)  1
Dizziness *  2/36 (5.56%)  2 1/37 (2.70%)  1
Lightheadedness *  5/36 (13.89%)  6 0/37 (0.00%)  0
Shakiness *  1/36 (2.78%)  1 0/37 (0.00%)  0
Unsteadiness *  1/36 (2.78%)  1 0/37 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
EMail: clinicaltrials@urlmutual.com
Layout table for additonal information
Responsible Party: Kristin Arnold, Vice President R&D, Mutual Pharmaceutical
ClinicalTrials.gov Identifier: NCT00658541     History of Changes
Other Study ID Numbers: 04065
First Submitted: April 9, 2008
First Posted: April 15, 2008
Results First Submitted: December 16, 2009
Results First Posted: January 20, 2010
Last Update Posted: May 3, 2011