Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

This study has been completed.

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00754962

Purpose

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

Condition	Intervention
Depression	Drug: protriptyline

MedlinePlus related topics: Depression

Drug Information available for: Protriptyline Protriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, 2-Period, 2-Way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: baseline, 2-period, 28 day washout ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	December 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

10 mg tablet

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754962

Locations

United States, New Jersey
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Benno G Roesch, MD

Advanced Biomedical Research

More Information

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director - Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	PROT-T10-PVFS-1
Study First Received:	September 17, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00754962
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Protriptyline
Depression
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions
Antidepressive Agents, Tricyclic

ClinicalTrials.gov processed this record on January 13, 2009