Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
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→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
|
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
|
Outcome Measures
Primary Outcome Measures
- Cmax [predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]
Cmax of dapoxetine and mirodenafil
- Area Under Curve (AUC) [predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]
AUC of dapoxetine and mirodenafil
Secondary Outcome Measures
- 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]
Incidence rate of Adverse events
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- SK Chemicals Co., Ltd.
Investigators
- Principal Investigator: Min-Gul Kim, MD, PhD, Chonbuk National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SID123_DDI_I_2014