Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: Myrin© 2 (Rifampicin + Isoniazid); Rimactane® (Rifampicin)
Intervention description: Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg; One (1) capsule of Rifampicin 300 mg
Intervention MeSH terms: Rifampin; Isoniazid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioequivalence; rifampicin

Summary:

      This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2
      Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer
      Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg
      rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to
      determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects between the ages of 18 and 55 years, inclusive.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

          -  An informed consent document signed and dated by the subject.

          -  Subjects willing and able to comply with 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, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Any condition possibly affecting drug absorption (e.g., gastrectomy).

          -  A positive urine drug screen.

          -  History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces
             (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor)
             within 6 months of screening.

          -  Treatment with an investigational drug within 3 months (or as determined by the local
             requirement, whichever is longer) or 5 half-lives preceding the first dose of study
             medication.

          -  12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG
             should be repeated two more times and the average of the three QTc values should be
             used to determine the subject's eligibility.

          -  History of previous treatment for TB or is suspected of suffering from TB.

          -  Use of prescription or nonprescription drugs and dietary supplements within 7 days or
             5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal
             medication, herbal supplements and hormone replacement therapy must be discontinued 28
             days prior to the first dose of study medication. As an exception, acetaminophen /
             paracetamol may be used at doses of less than 1 g/day. Limited use of non-prescription
             medications that are not believed to affect subject safety or the overall results of
             the study may be permitted on a case-by-case basis following approval by the sponsor.

          -  Blood donation of approximately 1 pint (500 ml) within 56 days prior to dosing.

          -  A history of hypersensitivity to any of the study medications or related substances,
             or to any of the ingredients used in the study drug formulations.

          -  Unwilling or unable to comply with the Lifestyle guidelines described in this
             protocol.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.

          -  Recent history of diarrhea (2 weeks).

          -  Recent use of oral (2 weeks) or IV (2-3 months) antibiotics to assure normal bowel
             flora at study start.