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Trial record 39 of 121 for:    ZOLPIDEM AND Central Nervous System Depressants

Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00833937
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : August 18, 2009
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Zolpidem 10 mg tablets
Drug: AMBIEN® 10 mg tablets
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zolpidem (Test) First Ambien® (Reference) First
Hide Arm/Group Description Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout
Started 12 12
Completed 11 12
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Intervention
Started 11 12
Completed 11 12
Not Completed 0 0
Arm/Group Title Zolpidem (Test) First Ambien® (Reference) First Total
Hide Arm/Group Description Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period 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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
1
   8.3%
2
  16.7%
3
  12.5%
Male
11
  91.7%
10
  83.3%
21
  87.5%
Race, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Caucasian 9 7 16
Black 2 4 6
Hispanic 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Zolpidem Ambien®
Hide Arm/Group Description:
Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
Ambien® 10 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
117.313  (42.878) 116.452  (40.419)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem, Ambien®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Geometric Means
Estimated Value 99.7
Confidence Interval 90%
93.9 to 106
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
2.Primary Outcome
Title AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Zolpidem Ambien®
Hide Arm/Group Description:
Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
Ambien® 10 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
541.580  (279.254) 543.732  (273.918)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem, Ambien®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Geometric Means
Estimated Value 97.8
Confidence Interval 90%
92.6 to 103
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
3.Primary Outcome
Title AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Zolpidem Ambien®
Hide Arm/Group Description:
Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
Ambien® 10 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
530.272  (271.461) 531.866  (265.350)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem, Ambien®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Geometric Means
Estimated Value 97.9
Confidence Interval 90%
92.7 to 103
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00833937     History of Changes
Other Study ID Numbers: B016540
First Submitted: January 30, 2009
First Posted: February 2, 2009
Results First Submitted: July 6, 2009
Results First Posted: August 18, 2009
Last Update Posted: August 18, 2009