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Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg

Sponsor
SK Chemicals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02485028
Collaborator
(none)
36
Enrollment
6
Arms
1
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dapoxetine 30mg tablet
  • Drug: Mirodenafil 50mg tablet
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: M→D→D+M

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

Drug: Dapoxetine 30mg tablet

Drug: Mirodenafil 50mg tablet
Experimental: M→D+M→D

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

Drug: Dapoxetine 30mg tablet

Drug: Mirodenafil 50mg tablet
Experimental: D→M→D+M

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

Drug: Dapoxetine 30mg tablet

Drug: Mirodenafil 50mg tablet
Experimental: D+M→M→D

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

Drug: Dapoxetine 30mg tablet

Drug: Mirodenafil 50mg tablet
Experimental: D+M→D→M

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

Drug: Dapoxetine 30mg tablet

Drug: Mirodenafil 50mg tablet
Experimental: D→D+M→M

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

Drug: Dapoxetine 30mg tablet

Drug: Mirodenafil 50mg tablet

Outcome Measures

Primary Outcome Measures

  1. Cmax [predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]

    Cmax of dapoxetine and mirodenafil

  2. Area Under Curve (AUC) [predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]

    AUC of dapoxetine and mirodenafil

Secondary Outcome Measures

  1. Tmax [predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]

  2. 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]

  3. 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]

  4. 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]

  5. Number of Participants with Adverse Events [During 22 days from first administration of period 1]

    Incidence rate of Adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SK Chemicals Co., Ltd.

Investigators

  • Principal Investigator: Jae-Wook Ko, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02485028
Other Study ID Numbers:
  • SID123_DDI_I_2013
  • 12542
First Posted:
Jun 30, 2015
Last Update Posted:
Jun 30, 2015
Last Verified:
Jun 1, 2015
Keywords provided by SK Chemicals Co., Ltd.
Dapoxetine
Mirodenafil
DDI study
Additional relevant MeSH terms:
Mirodenafil

Study Results

No Results Posted as of Jun 30, 2015