- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247518
CKD-397 Drug-drug Interaction Study (A) (CKD-397DDI(A))
A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tamsulosin on Tadalafil in Healthy Male Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tamsulosin(0.2mg) on tadalafil(5mg) in healthy male subjects. Subjects will receive repeated dose of tadalafil (5mg*1t/day) or tadalafil (5mg*1t/day) / tamsulosin (0.2mg*1t/day) for 5days. Each treatment period was separated by a washout period of at least 10 days.
Each period of study will enroll 8 healthy male subjects. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Jeonju-si, Korea, Republic of
- Chonbuk National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy man age 19 years or more and less than 55 years old at the time of screening.
- BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
- Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
- Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
- Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Exclusion Criteria:
- Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Showing the value that corresponds to following laboratory parameters: AST or AST > 2* upper limit of normal range.
- Alcohol > 210g/week, within 6 months prior to the screening.
- Taking the medication involved in other clinical trials within two months before the first dose medication characters.
- Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.
- History of alcohol or drug abuse, within 1 year
- Positive result in urine drug test(Amphetamines, Cocaine, Opioid, Benzodiazepines, Cannabinoid)
- Positive result in Serology test(Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus), TPPA(qual)).
- Subject who takes an abnormal meal which can affect the ADME of drug.
- Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- Smoker (> 20cigarettes/day)
- Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
- Subject who done the whole blood donation within two months or component blood donation within 1 month prior to the first dosing.
- Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- Subject with taking any forms of organic nitrate periodically and/or intermittently.
- Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
- Subject with serious history of hypersensitivity or allergy to investigational product.
- Subject who Lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy (NAION).
- Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
- Orthostatic hypotension
- Subjects who is not able to comply with guidelines described in the protocol.
- Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group2: Treatment B + Treatment A, PO
Treatment A : Tamsulosin 0.2mg*1t for 5days, Treatment B : Tamsulosin 0.2mg*1t/day and Tadalafil 5mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.
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Other Names:
Other Names:
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Other: Group1: Treatment A + Treatment B, PO
Treatment A : Tadarafil 5mg*1t/day for 5days, Treatment B : Tadarafil 5mg*1t/day and Tamsulosin 0.2mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tadalafil 5mg AUCt(0-24)
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil 5mg Cmax
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
|
1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tadalafil Css,min
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil Css,av
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil Tss,max
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil t1/2
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil CL/F
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil Vd/F
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil fluctuation[(Css,max-Css,min)/Css,av]
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Tadalafil swing[(Css,max-Css,min)/Css,min]
Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Min Gul Kim, PhD, Chonbuk National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tadalafil
- Tamsulosin
Other Study ID Numbers
- 150DDI14012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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