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Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

Drug Interaction Potentiation Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02485041
Study type Interventional
Source SK Chemicals Co.,Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 2014
Completion date December 2014
View Details
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