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Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg

NCT ID: NCT02485028

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Interaction Potentiation

Keywords

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Dapoxetine Mirodenafil DDI study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M→D→D+M

Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3

Group Type EXPERIMENTAL

Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

M→D+M→D

Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3

Group Type EXPERIMENTAL

Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

D→M→D+M

Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3

Group Type EXPERIMENTAL

Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

D+M→M→D

Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3

Group Type EXPERIMENTAL

Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

D+M→D→M

Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3

Group Type EXPERIMENTAL

Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

D→D+M→M

Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3

Group Type EXPERIMENTAL

Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

Interventions

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Dapoxetine 30mg tablet

Intervention Type DRUG

Mirodenafil 50mg tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae-Wook Ko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Other Identifiers

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12542

Identifier Type: OTHER

Identifier Source: secondary_id

SID123_DDI_I_2013

Identifier Type: -

Identifier Source: org_study_id