Status:
COMPLETED
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Short Term Treatment of Insomnia
Eligibility:
All Genders
18-45 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00694187
Start Date
January 1 2004
End Date
February 1 2004
Last Update
January 23 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042