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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: reference drugs; Drug: RIN 150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02014272

B3801003

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Test

Experimental group

Description:

RIN 150 contains 150 rifampicin and 75 mg isoniazid

Treatment:

Drug: RIN 150

Reference

Active Comparator group

Description:

Individual references of rifampicin and isoniazid

Treatment:

Drug: reference drugs