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

Pfizer logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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