Trial Outcomes & Findings for Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions (NCT NCT00684814)
NCT ID: NCT00684814
Last Updated: 2012-04-20
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
2012-04-20
Participant Flow
Participant milestones
| Measure |
Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets
On the morning of Day 1 after an overnight fast of at least 10 hours, 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 after an overnight fast of at least 10 hours, 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 after an overnight fast of at least 10 hours, 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 after an overnight fast of at least 10 hours, 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
|
17
|
15
|
|
Washout Period of 7 Days
NOT COMPLETED
|
2
|
4
|
|
Second Intervention
STARTED
|
17
|
15
|
|
Second Intervention
COMPLETED
|
16
|
15
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets
On the morning of Day 1 after an overnight fast of at least 10 hours, 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 after an overnight fast of at least 10 hours, 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 after an overnight fast of at least 10 hours, 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 after an overnight fast of at least 10 hours, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
|
|---|---|---|
|
Washout Period of 7 Days
Adverse Event
|
1
|
2
|
|
Washout Period of 7 Days
Withdrawal by Subject
|
1
|
2
|
|
Second Intervention
Adverse Event
|
1
|
0
|
Baseline Characteristics
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
28.92 years
STANDARD_DEVIATION 8.64 • n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 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 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.
The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
Outcome measures
| Measure |
Zolpidem Tartrate 10 mg Tablets
n=31 Participants
Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
|
Ambien® 10 mg Tablets
n=31 Participants
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate
|
191.94 ng/mL
Standard Deviation 74.77
|
193.43 ng/mL
Standard Deviation 59.95
|
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 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.
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=31 Participants
Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
|
Ambien® 10 mg Tablets
n=31 Participants
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate
|
682.17 ng-hr/mL
Standard Deviation 285.78
|
692.47 ng-hr/mL
Standard Deviation 290.89
|
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 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.
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=31 Participants
Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
|
Ambien® 10 mg Tablets
n=31 Participants
Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate
|
723.14 ng-hr/mL
Standard Deviation 327.83
|
739.63 ng-hr/mL
Standard Deviation 351.51
|
Adverse Events
Zolpidem Tartrate 10 mg Tablets
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Ambien® 10 mg Tablets
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zolpidem Tartrate 10 mg Tablets
n=34 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.
|
Ambien® 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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Achy joints
|
2.9%
1/34 • Number of events 1
|
0.00%
0/36
|
|
Eye disorders
Diplopia
|
17.6%
6/34 • Number of events 6
|
16.7%
6/36 • Number of events 6
|
|
Nervous system disorders
Drowsiness
|
2.9%
1/34 • Number of events 1
|
0.00%
0/36
|
|
Nervous system disorders
Unsteadiness
|
8.8%
3/34 • Number of events 3
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Hiccups
|
8.8%
3/34 • Number of events 3
|
13.9%
5/36 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Number of events 2
|
0.00%
0/36
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34
|
11.1%
4/36 • Number of events 4
|
|
Infections and infestations
Head cold
|
0.00%
0/34
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tightness in lungs
|
0.00%
0/34
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/34
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/34
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Confusion
|
2.9%
1/34 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Slurred speech
|
0.00%
0/34
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Visual disturbances
|
0.00%
0/34
|
2.8%
1/36 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60