Drug Interaction Potentiation Clinical Trial
Official title:
An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers
Verified date | June 2015 |
Source | SK Chemicals Co.,Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 55 Years |
Eligibility |
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 - eGFR < lower limit of normal range - Subject considered as unsuitable based on medical judgement by investigators |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SK Chemicals Co.,Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Tmax | predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | Number of Participants with Adverse Events | Incidence rate of Adverse events | During 22 days from first administration of period 1 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03789032 -
Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
|
Phase 1 | |
Completed |
NCT03706222 -
Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan
|
||
Completed |
NCT02191358 -
YouScript IMPACT Registry
|
N/A | |
Completed |
NCT01896557 -
Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
|
Phase 4 | |
Completed |
NCT03011463 -
Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1
|
Phase 1 | |
Completed |
NCT02485041 -
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg
|
Phase 1 | |
Completed |
NCT01477424 -
A Drug-Drug Interaction Study of Warfarin and PA21
|
Phase 1 | |
Completed |
NCT01477411 -
A Drug-Drug Interaction Study of Digoxin and PA21
|
Phase 1 | |
Completed |
NCT05558150 -
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac
|
Phase 1 | |
Completed |
NCT03493698 -
A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03126578 -
Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam
|
Phase 1 | |
Completed |
NCT01369186 -
Drug Drug Interactions of Aspirin and P2Y12-inhibitors
|
Phase 4 | |
Completed |
NCT02378220 -
Pharmacogenetic Testing Among Home Health Patients
|
N/A | |
Completed |
NCT01324752 -
A Drug-Drug Interaction Study of Losartan and PA21
|
Phase 1 | |
Completed |
NCT02500667 -
A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT03801733 -
Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin
|
Phase 1 | |
Completed |
NCT03801759 -
Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide
|
Phase 1 | |
Completed |
NCT03801746 -
Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin
|
Phase 1 | |
Completed |
NCT01736371 -
Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
|
N/A | |
Completed |
NCT05237297 -
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole
|
Phase 1 |