Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow for 3 periods

Period 1:   First Intervention

	Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets	Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets
STARTED	19	19
COMPLETED	19	19
NOT COMPLETED	0	0

Period 2:   Washout Period of 7 Days

	Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets	Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets
STARTED	19	19
COMPLETED	17	15
NOT COMPLETED	2	4
Adverse Event	1	2
Withdrawal by Subject	1	2

Period 3:   Second Intervention

	Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets	Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets
STARTED	17	15
COMPLETED	16	15
NOT COMPLETED	1	0
Adverse Event	1	0

Reporting Groups

	Description
Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets	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.

Baseline Measures

	Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets
Number of Participants   [units: participants]	38
Age   [units: participants]
<=18 years	0
Between 18 and 65 years	38
>=65 years	0
Age   [units: years] Mean ± Standard Deviation	28.92  ± 8.64
Gender   [units: participants]
Female	21
Male	17
Race (NIH/OMB)   [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	5
White	33
More than one race	0
Unknown or Not Reported	0
Region of Enrollment   [units: participants]
United States	38

1.  Primary:

Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate   [ 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 ]

2.  Primary:

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate   [ 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 ]

3.  Primary:

Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate   [ 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 ]