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Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

NCT ID: NCT02485041

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

2014-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

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

Intervention Type DRUG

Tablet, Orally administered

Mirodenafil 100mg

Intervention Type DRUG

Table, Orally administered

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

Intervention Type DRUG

Tablet, Orally administered

Mirodenafil 100mg

Intervention Type DRUG

Table, Orally administered

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

Intervention Type DRUG

Tablet, Orally administered

Mirodenafil 100mg

Intervention Type DRUG

Table, Orally administered

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

Intervention Type DRUG

Tablet, Orally administered

Mirodenafil 100mg

Intervention Type DRUG

Table, Orally administered

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

Intervention Type DRUG

Tablet, Orally administered

Mirodenafil 100mg

Intervention Type DRUG

Table, Orally administered

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

Intervention Type DRUG

Tablet, Orally administered

Mirodenafil 100mg

Intervention Type DRUG

Table, Orally administered

Interventions

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Dapoxetine 30mg

Tablet, Orally administered

Intervention Type DRUG

Mirodenafil 100mg

Table, Orally administered

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
* 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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Min-Gul Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Other Identifiers

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SID123_DDI_I_2014

Identifier Type: -

Identifier Source: org_study_id