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 an investigational small molecule being studied in healthy volunteers. It is a fixed dose combination formulation containing rifampicin, isoniazid, ethambutol and pyrazinamide per tablet. It is being developed by Pfizer, Inc. for use in healthy adults.
Myrin P Forte is a fixed dose combination formulation that contains four active ingredients per tablet: rifampicin, isoniazid, ethambutol and pyrazinamide. These are anti-tuberculosis medications combined into a single tablet for oral administration.
Myrin P Forte is being developed by Pfizer, Inc., which is listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this fixed dose combination product in healthy adult volunteers.
Myrin P Forte is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for its intended use.
Myrin P Forte has one completed clinical trial registered as NCT01399788. This was a Phase 1 bioequivalence study conducted in Singapore with 36 healthy adult participants. The study compared the fixed dose combination formulation to equivalent doses of single drug reference preparations following oral administration.
Myrin P Forte is not the same as a single-drug tuberculosis treatment. It is a fixed dose combination product that contains four drugs in one tablet: rifampicin, isoniazid, ethambutol and pyrazinamide. This combination approach is designed to simplify dosing compared to taking each drug separately.