Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Myrin P Forte · 1 trial · 1 indication
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...
Myrin P Forte is a fixed dose combination small molecule developed by Pfizer, Inc. (ticker PFE). It combines rifampicin, isoniazid, ethambutol and pyrazinamide in a single tablet, the standard drugs used to treat tuberculosis. It has been studied in a Phase 1 bioequivalence trial in healthy adult volunteers.
Myrin P Forte is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical study of the fixed dose combination tablet. The product combines four anti-tuberculosis drugs, rifampicin, isoniazid, ethambutol and pyrazinamide, into one formulation.
Myrin P Forte has been studied in Phase 1 clinical development. Its single registered trial, NCT01399788, was a Phase 1 bioequivalence study that has been completed. The program has no active trials at this time, and the available information does not indicate that the product is approved.
Myrin P Forte has been evaluated in one clinical trial, NCT01399788, titled a bioequivalence study comparing a fixed dose combination formulation of Myrin P Forte containing rifampicin, isoniazid, ethambutol and pyramizamide per tablet to equivalent doses of single drug reference preparations. The Phase 1 study enrolled 36 healthy adults in Singapore and is completed.
Myrin P Forte is a fixed dose combination of rifampicin, isoniazid, ethambutol and pyrazinamide, the four drugs used together in tuberculosis treatment. Its only registered trial was conducted in healthy adult volunteers to compare the combination tablet against single drug reference preparations, so the studied population was healthy volunteers rather than patients.
The Myrin P Forte trial NCT01399788 was a Phase 1, randomized, active controlled bioequivalence study. It enrolled 36 healthy adults aged 21 years and older in Singapore and was not double blinded. The study compared the fixed dose combination tablet with equivalent doses of single drug reference preparations given orally, and it is completed.