Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

Roxane Laboratories

Status: Completed

Conditions: Depression

Treatments: Drug: protriptyline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754962

PROT-T10-PVFS-1

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)