Trial Outcomes & Findings for Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets (NCT NCT00658541)
NCT ID: NCT00658541
Last Updated: 2011-05-03
Results Overview
The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
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
Results posted on
2011-05-03
Participant Flow
Participant milestones
| Measure |
Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets
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.
|
Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets
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.
|
|---|---|---|
|
First Intervention
STARTED
|
19
|
19
|
|
First Intervention
COMPLETED
|
19
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
19
|
19
|
|
Washout Period of 7 Days
COMPLETED
|
18
|
17
|
|
Washout Period of 7 Days
NOT COMPLETED
|
1
|
2
|
|
Second Intervention
STARTED
|
18
|
17
|
|
Second Intervention
COMPLETED
|
18
|
17
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets
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.
|
Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets
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.
|
|---|---|---|
|
Washout Period of 7 Days
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
Baseline characteristics by cohort
| Measure |
Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets
n=38 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
30.21 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 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.
The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
Outcome measures
| Measure |
Zolpidem Tartrate 10 mg Tablets
n=35 Participants
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.
|
Ambien® 10 mg Tablets
n=35 Participants
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate
|
123.61 ng/mL
Standard Deviation 42.45
|
131.92 ng/mL
Standard Deviation 45.02
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 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.
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.
Outcome measures
| Measure |
Zolpidem Tartrate 10 mg Tablets
n=35 Participants
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.
|
Ambien® 10 mg Tablets
n=35 Participants
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate
|
518.69 ng-hr/mL
Standard Deviation 194.66
|
518.68 ng-hr/mL
Standard Deviation 184.35
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 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.
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
Outcome measures
| Measure |
Zolpidem Tartrate 10 mg Tablets
n=35 Participants
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.
|
Ambien® 10 mg Tablets
n=35 Participants
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate
|
560.88 ng-hr/mL
Standard Deviation 234.32
|
561.96 ng-hr/mL
Standard Deviation 230.63
|
Adverse Events
Zolpidem Tartrate 10 mg Tablets
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ambien® 10 mg Tablets
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zolpidem Tartrate 10 mg Tablets
n=36 participants at risk
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.
|
Ambien® 10 mg Tablets
n=37 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Blurred vision
|
0.00%
0/36 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Nervous system disorders
Sedation
|
0.00%
0/36 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Nervous system disorders
Confusion
|
0.00%
0/36 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Number of events 2 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Nervous system disorders
Lightheadedness
|
13.9%
5/36 • Number of events 6 • 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.
|
0.00%
0/37 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Eye disorders
Diplopia
|
5.6%
2/36 • Number of events 2 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
Nervous system disorders
Shakiness
|
2.8%
1/36 • Number of events 1 • 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.
|
0.00%
0/37 • 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.
|
|
Nervous system disorders
Unsteadiness
|
2.8%
1/36 • Number of events 1 • 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.
|
0.00%
0/37 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60