CKD-397 Drug-drug Interaction Study (B) (NCT02247505) | Clinical Trial Compass
CompletedPhase 1
CKD-397 Drug-drug Interaction Study (B)
South Korea29 participantsStarted 2014-09
Plain-language summary
The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic properies of tamsulosin
Who can participate
Age range19 Years – 55 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …