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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02485028
Other study ID # SID123_DDI_I_2013
Secondary ID 12542
Status Completed
Phase Phase 1
First received June 10, 2015
Last updated June 25, 2015
Start date October 2013
Est. completion date November 2013

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 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 2013
Est. primary completion date November 2013
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

- eGFR < lower 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


Intervention

Drug:
Dapoxetine 30mg tablet

Mirodenafil 50mg tablet


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
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