Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Interaction Potentiation
• Intervention / Treatment: Drug: Dapoxetine 30mg; Drug: Mirodenafil 100mg

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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+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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Cmax of dapoxetine and mirodenafil	predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Area Under Curve (AUC)	AUC of dapoxetine and mirodenafil	predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
t1/2		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
CL/F		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Vd/F		predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Number of Participants with Adverse events	Incidence rate of Adverse events	During 22 days from first administration of period 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Dapoxetine; Mirodenafil; DDI study
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Mirodenafil
• Other Study ID Numbers: SID123_DDI_I_2014