Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Not Applicable

Completed

• Conditions: Short Term Treatment of Insomnia

• Registration Number: NCT00694187
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two Period, Seven day washout

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Houston, Texas, United States