Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

Roxane Laboratories40 enrolled

Overview

The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) 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

Short Term Treatment of Insomnia

Interventions

ZaleplonDRUG

Short term treatment of insomnia

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 Zaleplon or any comparable or similar product.

Locations (1)

Novum Pharmaceutical Research Services

Houston, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence

Data from ClinicalTrials.gov

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