Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: Zolpidem (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Alan K Copa, Principal Investigator, Affiliation: PRACS Institute, Ltd.
Summary
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.
Clinical Details
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information
Starting date: March 2004
Ending date: March 2004
Last updated: February 5, 2008
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