Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

N/ACompletedNCT00754962

Roxane Laboratories38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

protriptylineDRUG

10 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Advanced Biomedical Research

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

Bioequivalence

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

Data from ClinicalTrials.gov

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