Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg

NCT02485028 | Completed Phase 1

• 2 other identifiers: SID123_DDI_I_201312542
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Drug Interaction Potentiation

Keywords

Dapoxetine; Mirodenafil; DDI study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

  During 22 days from first administration of period 1

Study Arms (6)

M→D→D+M

EXPERIMENTAL

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

Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet

M→D+M→D

EXPERIMENTAL

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

Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet

D→M→D+M

EXPERIMENTAL

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

Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet

D+M→M→D

EXPERIMENTAL

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

Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet

D+M→D→M

EXPERIMENTAL

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

Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet

D→D+M→M

EXPERIMENTAL

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

Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet

Interventions

Dapoxetine 30mg tablet DRUG

D+M→D→M; D+M→M→D; D→D+M→M; D→M→D+M; M→D+M→D; M→D→D+M

Mirodenafil 50mg tablet DRUG

D+M→D→M; D+M→M→D; D→D+M→M; D→M→D+M; M→D+M→D; M→D→D+M

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

MeSH Terms

Interventions

dapoxetine; Tablets; mirodenafil

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jae-Wook Ko, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 30, 2015
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 30, 2015

Record last verified: 2015-06