NCT02485041

Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30 mg and Mirodenafil 100 mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.

Detailed description

Healthy male volunteers were randomized into one group among 6 sequential groups and were administered alone or in combination with dapoxetine 30mg mirodenafil 100mg in each period. Bloods were obtained at each time for pharmacokinetic analysis. Safety evaluation was also done during entire study period.

Conditions

• Drug Interaction Potentiation

Interventions

Type	Name	Description
DRUG	Dapoxetine 30mg	Tablet, Orally administered
DRUG	Mirodenafil 100mg	Table, Orally administered

Timeline

• Start date: 2014-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-06-30
• Last updated: 2015-06-30