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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Myrin P Forte (Drug); Single drug references (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against
reference drug in healthy volunteers.
Clinical Details
Official title: An Open Label, Single Dose, 2-Way Cross-Over Randomized Bioequivalence Study Comparing a Fixed Dose Combination Formulation, Myrin®-p Forte, (Contains 150 Mg Rifampicin, 75 Mg Isoniazid, 275 Mg Ethambutol and 400 Mg Pyrazinamide Per Tablet) to an Equivalent Dose of Single Drug Reference Preparations of Rifampicin, Isoniazid, Ethambutol and Pyrazinamide Following Oral Administration in Healthy Adults Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)Maximum Observed Plasma Concentration (Cmax) Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide
Secondary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞])Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide Plasma Decay Half-life (t1/2) Time to Reach Maximum Observed Plasma Concentration (Tmax)
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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:
- 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.
Locations and Contacts
Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: July 2011
Last updated: May 9, 2012
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