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

NCT ID: NCT01399788

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-08-31

Brief Summary

This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1.0

Test Myrin P Forte Contains 150mg Rifampicin, 75mg Isoniazid, 275mg Ethambutol, 400mg Pyrazinamide

Group Type: ACTIVE_COMPARATOR

Myrin P Forte

Intervention Type: DRUG

Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose

2.0

Reference Single drug reference preparations contain Rifampicin, Isoniazid, Ethambutol, Pyrazinamide

Group Type: ACTIVE_COMPARATOR

Single drug references

Intervention Type: DRUG

containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents

Interventions

Myrin P Forte

Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose

Intervention Type: DRUG

Single drug references

containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Singapore, , Singapore

Countries

Singapore

References

Wang HF, Wang R, O'Gorman M, Crownover P, Naqvi A, Jafri I. Bioequivalence of fixed-dose combination Myrin(R)-P Forte and reference drugs in loose combination. Int J Tuberc Lung Dis. 2013 Dec;17(12):1596-601. doi: 10.5588/ijtld.13.0190.

Reference Type: DERIVED

PMID: 24200275 (View on PubMed)

Other Identifiers

B3801002

Identifier Type: -

Identifier Source: org_study_id