Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Propafenone · 1 trial · 1 indication
Maximum observed concentration in plasma
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method
| Arm | Type | Description |
|---|---|---|
| Sequence ABAB | OTHER | 16 subjects assigned to the sequence ABAB will receive a single 300 mg dose of the test product Propafenone (1 x 300 mg film-coated tablet), marked as A in the sequence, in Periods 1 and 3 and a single 300 mg dose of the reference product Rytmonorm (1 x 300 mg film-coated tablet), marked as B in the sequence, in periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence BABA | OTHER | 16 subjects assigned to the sequence BABA will receive a single 300 mg dose of the reference product Rytmonorm (1 x 300 mg film-coated tablet), marked as B in the sequence, in Periods 1 and 3 and a single 300 mg dose of the test product Propafenone (1 x 300 mg film-coated tablet), marked as A in the sequence, in periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Name | Type | Description |
|---|---|---|
| Propafenone | DRUG | Propafenone is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 300 mg of propafenone hydrochloride. |
| Rytmonorm | DRUG | Rytmonorm is manufactured by Famar Lyon, France (MAH: Mylan Healthcare GmbH, Germany). Each tablet contains 300 mg of propafenone hydrochloride. |
Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy adult male or female volunteer 4. A female volunteer must meet one of the following criteria: 1. P...
Propafenone is a small molecule drug being studied for bioequivalence, meaning it is being tested to compare two formulations of propafenone 300 mg film-coated tablets in healthy adult volunteers. The study evaluates the drug under fasting conditions after a single oral dose administration.
Propafenone is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is conducting a Phase 1 bioequivalence study to compare two formulations of the drug in healthy volunteers.
Propafenone is in Phase 1 clinical development. The drug is investigational and not yet approved, as it is being studied in a bioequivalence trial to assess the pharmacokinetic profile of two formulations in healthy adult volunteers.
Propafenone is being studied in one completed Phase 1 clinical trial, identified as NCT03915340. This trial is a bioequivalence study of two formulations of propafenone 300 mg film-coated tablets in healthy adult volunteers under fasting conditions, with 32 participants enrolled in Canada.
Propafenone is a small molecule drug being developed by Ligand Pharmaceuticals Incorporated. It is being studied for bioequivalence, which means the trial compares two formulations of the same drug to ensure they are equivalent in terms of pharmacokinetics and safety.