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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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01399788
Pfizer
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

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[email protected]

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