CKD-397 Drug-drug Interaction Study (A)

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic properties of tadalafil

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Tadalafil; Tamsulosin

Criteria

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.