Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT00754962
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	baseline, 2-period, 28 day washout

Trial Locations

Locations (1)

Advanced Biomedical Research; 🇺🇸 Hackensack, New Jersey, United States