Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Propafenone · 1 trial · 1 indication
Two formulations of propafenone hydrochloride
| Arm | Type | Description |
|---|---|---|
| Propafenone | OTHER | Open label comparison of 2 formulations |
| Name | Type | Description |
|---|---|---|
| Propafenone | DRUG | Comparison of drug from 2 manufacturing sites |
Inclusion Criteria: * Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Body weight greater than or equal to 50kg and BMI within the range 18.5 - 31.0kg/m2 (inclusive). * Healthy as determined by a responsible and experienced physician, based on...
Propafenone is a small molecule drug in development for cardiac arrhythmia. It is being studied as a treatment for irregular heart rhythms. The drug is currently in Phase 1 clinical development and is being developed by GSK plc.
Propafenone is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The drug is currently in Phase 1 clinical development for the treatment of cardiac arrhythmia.
Propafenone is in Phase 1 clinical development. It is an investigational drug being studied for cardiac arrhythmia. The drug has completed one Phase 1 clinical trial, which was a bioequivalence study. Propafenone is not yet approved and remains in clinical development.
Propafenone has one completed clinical trial, NCT01956487, titled "Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites." This Phase 1 study enrolled 38 participants in the United States and evaluated healthy volunteers. The trial was not randomized, double-blind, or controlled.
Propafenone is the active ingredient in RYTHMOL SR, a brand-name formulation. A completed clinical trial, NCT01956487, studied the bioequivalence of RYTHMOL SR manufactured at two different sites. This trial was conducted in healthy volunteers to compare the two formulations.