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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.