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 Details — Status: Completed

Administrative data

• NCT number: NCT02485041
• Other study ID #: SID123_DDI_I_2014
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2015
• Last updated: June 25, 2015
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male adults aged between 19 and 55

• Body mass index (BMI) in the range of 19 to 27 kg/m2

• Understand the requirements of the study and voluntarily consent to participate in the study

• Available for the entire study period

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

• caffeine(coffee,tea,coke)> 4cups/day

• smoking > 10 cigarettes/day

• alcohol > 140g/week

• 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:

• AST(SGOT) or ALT(SGPT) or total bilirubin > 1.5 x upper limit of normal range

• Subject considered as unsuitable based on medical judgement by investigators

Study Design

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

Related Conditions & MeSH terms

• Drug Interaction Potentiation

Intervention

Drug:
• Dapoxetine 30mg
Tablet, Orally administered
• Mirodenafil 100mg
Table, Orally administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Cmax of dapoxetine and mirodenafil	predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose	No
Primary	Area Under Curve (AUC)	AUC of dapoxetine and mirodenafil	predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose	No
Secondary	Tmax		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose	No
Secondary	t1/2		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose	No
Secondary	CL/F		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose	No
Secondary	Vd/F		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose	No
Secondary	Number of Participants with Adverse events	Incidence rate of Adverse events	During 22 days from first administration of period 1	Yes