Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions
Not Applicable
Completed
- Conditions
- Migraine
- Registration Number
- NCT01161667
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fasted conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
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Exclusion Criteria
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 9 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Charles River Northwest Kinetics
🇺🇸Tacoma, Washington, United States