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

• Drug: RIN 150
  
  Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.
• Drug: reference drugs
  
  Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.

• Experimental: Test
  
  RIN 150 contains 150 rifampicin and 75 mg isoniazid
  Intervention: Drug: RIN 150
• Active Comparator: Reference
  
  Individual references of rifampicin and isoniazid
  Intervention: Drug: reference drugs

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.