Clinical trial NCT02485028: Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction Potentiation
Keywords: Dapoxetine
Mirodenafil
DDI study
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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
  * eGFR \< lower limit of normal range
* Subject considered as unsuitable based on medical judgement by investigators

Primary outcomes:
measure: Cmax
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
measure: Area Under Curve (AUC)
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Secondary outcomes:
measure: Tmax
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
measure: t1/2
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
measure: CL/F
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
measure: Vd/F
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
measure: Number of Participants with Adverse Events
timeFrame: During 22 days from first administration of period 1
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Jae-Wook Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: