Status:
COMPLETED
Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Depression
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions
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 Protriptyline or any comparable or similar product.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00754962
Start Date
December 1 2006
End Date
January 1 2007
Last Update
January 23 2018
Active Locations (1)
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1
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601