Expired Study
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Fargo, North Dakota 58104


Purpose:

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Criteria:

Inclusion Criteria: - No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: - Positive test for HIV, Hepatitis B, or Hepatitis C. - Treatment with known enzyme altering drugs. - History of allergic or adverse response to Zolpidem or any comparable or similar product.


Study is Available At:


Original ID:

ZOLP-02


NCT ID:

NCT00602719


Secondary ID:


Study Acronym:


Brief Title:

Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions


Official Title:

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fed Conditions


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

West-Ward Pharmaceutical


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alan K Copa
Principal Investigator
PRACS Institute, Ltd.

Study Dates

Start Date:March 2004
Completion Date:March 2004
Completion Type:Actual
Primary Completion Date:March 2004
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 19, 2018
First Received Date:January 15, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Time Frame:Baseline, Two period, Seven day washout
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Zolpidem

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Roxane Laboratories

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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