NCT02014272 - A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers | Crick

Overview

This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

28

Conditions

Healthy Volunteers

Interventions

RIN 150DRUG

Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.

reference drugsDRUG

Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV serology results; * Pregnant or nursing female; * History or active tuberculosis; * Participated in investigational drug studies within 3 months; * Used prescription or nonprescription drugs within 7 days or 5 half-lives.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.