Overview
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions
Status:
Completed
Completed
Trial end date:
2004-03-01
2004-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Roxane LaboratoriesTreatments:
Zolpidem
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.