Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Roxane Laboratories39 enrolled

Overview

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

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

Time frame: Baseline, Two Period, Seven day washout

Data from ClinicalTrials.gov

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