Phase 1
Completed N=36
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
Healthy Volunteers
Source: ClinicalTrials.gov NCT01399788 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 79360.0; 77180.0; 20550.0; 18800.0 ng*hr/mL
Summary
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
79360.0; 77180.0; 20550.0; 18800.0; 15070.0; 15170.0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
12120.0; 11830.0; 4418.0; 4237.0; 2771.0; 2865.0 | — |
| PRIMARY Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide |
453500; 447900 | — |
| PRIMARY Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide |
33890.0; 35580.0 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞]) |
80940.0; 78400.0; 21210.0; 19460.0; 17150.0; 17050.0 | — |
| SECONDARY Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide |
471000; 464800 | — |
| SECONDARY Plasma Decay Half-life (t1/2) |
3.6630; 3.4290; 3.7340; 3.9470; 7.7430; 7.6390 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.00; 1.50; 1.02; 1.00; 2.77; 2.48 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01399788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.