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Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

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ClinicalTrials.gov Identifier: NCT02485041
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Drug: Dapoxetine 30mg Drug: Mirodenafil 100mg Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
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 30 mg and Mirodenafil 100 mg in Healthy Male Volunteers
Study Start Date : November 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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, Orally administered

Drug: Mirodenafil 100mg
Table, Orally administered

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, Orally administered

Drug: Mirodenafil 100mg
Table, Orally administered

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, Orally administered

Drug: Mirodenafil 100mg
Table, Orally administered

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, Orally administered

Drug: Mirodenafil 100mg
Table, Orally administered

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, Orally administered

Drug: Mirodenafil 100mg
Table, Orally administered

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, Orally administered

Drug: Mirodenafil 100mg
Table, Orally administered




Primary Outcome Measures :
  1. Cmax [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During 22 days from first administration of period 1 ]
    Incidence rate of Adverse events



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485041


Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: Min-Gul Kim, MD, PhD Chonbuk National University Hospital

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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02485041     History of Changes
Other Study ID Numbers: SID123_DDI_I_2014
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Keywords provided by SK Chemicals Co., Ltd.:
Dapoxetine
Mirodenafil
DDI study
Additional relevant MeSH terms:
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Mirodenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action