Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Drug Interaction Potentiation

Treatments: Drug: Dapoxetine 30mg; Drug: Mirodenafil 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02485041

SID123_DDI_I_2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

M→D→D+M

Experimental group

Description:

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

Treatment:

Drug: Mirodenafil 100mg

Drug: Dapoxetine 30mg

M→D+M→D

Experimental group

Description:

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

Treatment:

Drug: Mirodenafil 100mg

Drug: Dapoxetine 30mg

D→M→D+M

Experimental group

Description:

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

Treatment:

Drug: Mirodenafil 100mg

Drug: Dapoxetine 30mg

D→D+M→M

Experimental group

Description:

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

Treatment:

Drug: Mirodenafil 100mg

Drug: Dapoxetine 30mg

D+M→M→D

Experimental group

Description:

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

Treatment:

Drug: Mirodenafil 100mg

Drug: Dapoxetine 30mg

D+M→D→M

Experimental group

Description:

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

Treatment:

Drug: Mirodenafil 100mg

Drug: Dapoxetine 30mg