Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

This study has been completed.

Study NCT00833937 Information provided by Teva Pharmaceuticals USA

First Received on January 30, 2009. Last Updated on July 6, 2009 History of Changes

Results First Received: July 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Zolpidem 10 mg tablets Drug: AMBIEN® 10 mg tablets

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Zolpidem (Test) First	Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
Ambien® (Reference) First	Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period

Participant Flow for 3 periods

Period 1: First Intervention

	Zolpidem (Test) First	Ambien® (Reference) First
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Period 2: Washout

	Zolpidem (Test) First	Ambien® (Reference) First
STARTED	12	12
COMPLETED	11	12
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

Period 3: Second Intervention

	Zolpidem (Test) First	Ambien® (Reference) First
STARTED	11	12
COMPLETED	11	12
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Zolpidem (Test) First	Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
Ambien® (Reference) First	Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period

Baseline Measures

	Zolpidem (Test) First	Ambien® (Reference) First	Total
Number of Participants [units: participants]	12	12	24
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	12	12	24
>=65 years	0	0	0
Gender [units: participants]
Female	1	2	3
Male	11	10	21
Race, Customized [units: Participants]
Caucasian	9	7	16
Black	2	4	6
Hispanic	1	1	2
Region of Enrollment [units: participants]
United States	12	12	24

Outcome Measures

Show All Outcome Measures

1. Primary:

Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ]

Show Outcome Measure 1

2. Primary:

AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ]

Show Outcome Measure 2

3. Primary:

AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 24 hour period ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00833937 History of Changes
Other Study ID Numbers:	B016540
Study First Received:	January 30, 2009
Results First Received:	July 6, 2009
Last Updated:	July 6, 2009
Health Authority:	United States: Institutional Review Board