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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

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

Page last updated: August 23, 2015

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