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
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
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Subject has a history such as liver diseases, kidneys, digestive system, respiratory system, endocrine system, nervous psychiatric, blood, cancer, cardiovascular diseases
Subject with clinically significant vital signs (sitting position blood pressure) (90 mmHg > systolic blood pressure ≥ 140 mmHg, 60 mmHg > diastolic blood pressure ≥ 90 mmHg)
History of drug abuse
History of caffeine, alcohol, smoking abuse
Consumption of any grapefruit or grapefruit-containing juices over 1 cup a day
Previously donate whole blood within 60 days or component blood within 30 days
Subject has taken drugs which affects the ADME of investigational products
Subject with known for hypersensitivity reactions to mirodenafil/ dapoxetine or other drugs
Inadequate laboratory test result:
Subject considered as unsuitable based on medical judgement by investigators