Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions

Roxane Laboratories30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia

Interventions

ZolpidemDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

PRACS Institute, Ltd.

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Seven day washout

Data from ClinicalTrials.gov

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