Back to resultsBioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
Primary Purpose
Short Term Treatment of Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zaleplon
Sponsored by
About this trial
This is an interventional treatment trial for Short Term Treatment of Insomnia
Eligibility 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 Zaleplon or any comparable or similar product.
Sites / Locations
- Novum Pharmaceutical Research Services
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00694317
Brief Title
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Term Treatment of Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zaleplon
Other Intervention Name(s)
Sonata
Intervention Description
Short term treatment of insomnia
Primary Outcome Measure Information:
Title
Bioequivalence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Zaleplon or any comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So Ran Hong, M.D.
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
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