Status:
COMPLETED
CKD-397 Drug-drug Interaction Study (B)
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Healty Male Volunteers
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic properies of tamsulosin
Detailed Description
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tadalafil(5mg) on tamsulosin(0.2mg) in healthy male subjects Subjects will rece...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02247505
Start Date
September 1 2014
End Date
December 1 2014
Last Update
August 20 2015
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, South Korea