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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01956487 | Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites | PHASE1 | COMPLETED | 38 | — | — | Apr 11, 2012 | Jun 27, 2012 | Jun 12, 2017 | 1 | United States |
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...