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OpenTrials
Completed

NCT Number: NCT00754962

Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Biomedical Research

Hackensack, New Jersey, 07601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

protriptyline

Drug

10 mg tablet

Other names: Vivactil

Primary outcomes

  1. Bioequivalence

    Time frame: baseline, 2-period, 28 day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, 2-Period, 2-way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 18, 2008
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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