Clinical trial NCT02485041: Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg
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 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 100mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.

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.

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
* 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: Chonbuk National University Hospital
name: Min-Gul Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: