Status:
COMPLETED
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.
Eligibility Criteria
Inclusion
- Healthy, male or female, 21 to 55 years of age, body weight no less than 55 kg, Body mass index (BMI) of 17.5 to 30.5 kg/m2. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) or clinical laboratory tests.
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion
- 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 Human Immunodeficiency Virus (HIV) serology results.
- pregnant or nursing female,
- alcohol, drug, smoke user,
- sensitive to any study medication or related component,
- History or active gout,
- History or active tuberculosis,
- Known optic neuritis or other ophthalmological conditions.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01399788
Start Date
July 1 2011
End Date
August 1 2011
Last Update
April 5 2017
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770