Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Felodipine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single-arm | OTHER | 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) |
| Name | Type | Description |
|---|---|---|
| Candesartan (test) | DRUG | 16 mg oral tablet, single dose |
| Felodipine (test) | DRUG | 5 mg oral extended release tablet, single dose |
| Candesartan Cilexetil | DRUG | 16 mg oral tablet, single dose |
| Felodipine | DRUG | 5 mg oral extended release tablet, single dose |
Inclusion Criteria: * Healthy volunteers * BMI \> or = 19 and \< or = 28 (Dietary Guidelines Advisory Committee, 2005) Exclusion Criteria: * Not healthy * Chronic drug intake
Felodipine is a small molecule drug being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetic interaction with candesartan after a specific meal. The drug is investigational and not yet approved for any indication.
Felodipine is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this small molecule drug, which is currently in Phase 1 development for use in healthy volunteers.
Felodipine is in Phase 1 clinical development. It has one completed trial with 36 participants, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.
Felodipine has one completed clinical trial, NCT00905333, titled 'Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal.' This Phase 1 study enrolled 36 healthy volunteers in Brazil and was not randomized or double-blinded.
Felodipine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial, NCT00905333, was a pharmacokinetic interaction study in healthy volunteers, and the drug remains under clinical investigation.