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Completed

NCT Number: NCT02485028

Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg

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.

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Key information

Conditions

Drug Interaction Potentiation

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapoxetine 30mg tablet

Drug

Mirodenafil 50mg tablet

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2015
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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