Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01399788 | 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 | PHASE1 | COMPLETED | 36 | — | — | Jul 1, 2011 | Aug 1, 2011 | Apr 5, 2017 | 1 | Singapore |
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of last measured concentration (AUClast).
AUClast\[dn\] = Dose normalized area under the plasma concentration-time curve (AUC\[dn\]) from time zero (pre-dose) to the time of last measured concentration. It is obtained from AUClast divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.
It is obtained from Cmax divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.
| Arm | Type | Description |
|---|---|---|
| 1.0 | ACTIVE_COMPARATOR | Test Myrin P Forte Contains 150mg Rifampicin, 75mg Isoniazid, 275mg Ethambutol, 400mg Pyrazinamide |
| 2.0 | ACTIVE_COMPARATOR | Reference Single drug reference preparations contain Rifampicin, Isoniazid, Ethambutol, Pyrazinamide |
| Name | Type | Description |
|---|---|---|
| Myrin P Forte | DRUG | Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose |
| Single drug references | DRUG | containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents |
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...