Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

November 30, 2011

Study Completion Date

December 31, 2011

Conditions
Healthy
Interventions
DRUG

SPO1101

A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 50mg), with a 7-day washout period between the formulations.

DRUG

SPO1101D

A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 100mg), with a 7-day washout period between the formulations.

All Listed Sponsors
lead

Seoul Pharma Co., Ltd.

INDUSTRY

NCT01769638 - Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers | Biotech Hunter | Biotech Hunter