Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
Overview
The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions
Full Title of Study: “A Single Dose, 2-Period, 2-way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2007
Interventions
- Drug: protriptyline
- 10 mg tablet
Clinical Trial Outcome Measures
Primary Measures
- Bioequivalence
- Time Frame: baseline, 2-period, 28 day washout
Participating in This Clinical Trial
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 Protriptyline or any comparable or similar product.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Roxane Laboratories
- Provider of Information About this Clinical Study
- Elizabeth Ernst, Director – Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
- Overall Official(s)
- Benno G Roesch, MD, Principal Investigator, Advanced Biomedical Research
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