KCT0001243
Not yet recruiting
未知
A randomized, open-label, multiple dosing, 2-way crossover study to evaluate the pharmacokinetic effect of tamsulosin on tadalafil in healthy male volunteers
Chong Kun Dang0 sites16 target enrollmentTBD
ConditionsDiseases of The genitoruinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of The genitoruinary system
- Sponsor
- Chong Kun Dang
- Enrollment
- 16
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy man age 19 years or more and less than 55 years old at the time of screening.
- •2\. Body mass index(BMI) more than 17\.5kg / m2 and less than 30\.5kg / m2 and weight more than 55kg
- •3\. Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- •4\. 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 electrocardiography(ECG) test.
- •5\. 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 Institutional Review Board(IRB).
- •6\. Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Exclusion Criteria
- •1\. 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)
- •2\. Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •3\. Showing the value that corresponds to following laboratory parameters : AST(aspartate transaminase) or ALT(alanine transaminase) \> 2\* upper limit of normal range.
- •4\. Alcohol \> 210g/week, within 6 months prior to the screening.
- •5\. Taking the medication involved in other clinical trials within two months before the first dose medication characters.
- •6\. Sitting Systolic Blood Pressure \= 140 mmHg, Diastolic Blood Pressure \= 90 mmHg at the time of screening.
- •7\. History of alcohol or drug abuse, within 1 year
- •8\. Positive result in urine drug test(Amphetamines, Cocaine, Opioid, Benzodiazepines, Cannabinoid)
- •9\. Positive result in Serology test(Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus), TPPA(qual)).
- •10\. Subject who takes an abnormal meal which can affect the ADME(Absorption, Distribution, Metabolism, Excretion) of drug.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
Study to investigate the effect of tadalafil the pharmacokinetic properties of tamsulosinon after oral administration in healthy male volunteersDiseases of The genitoruinary systemKCT0001245Chong Kun Dang28
Not yet recruiting
Phase 1
A randomized, open-labeled, multiple-dose, two-way crossover design with two-period, two-treatment, two-sequence steady-state bioequivalence study of Venlafaxine Hydrochloride Extended-Release Capsules 150 mg and Efexor XR 150 mg Capsules in healthy, adult, Thai volunteers under fed conditioHealthy subjectsBioequivalence Venlafaxine Hydrochloride Extended-Release Capsules 150 mgTCTR20240706012Bio-innova Co., Ltd.44
Completed
Not Applicable
An open-label, multiple dose, randomized, two-way crossover study to evaluate the effects of BGG492 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteersEpilepsieEpilepsiafalling diseaseNL-OMON34415ovartis24
Active, not recruiting
Not Applicable
The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin and Fenofibric acidDiseases of the circulatory systemKCT0001438Chong Kun Dang30
Completed
Not Applicable
Clinical study to evaluate pharmacokinetic drug-drug interaction and safety between nebivolol and rosuvastatiDiseases of the circulatory systemKCT0001794Elyson Pharmaceutical44