Clinical trial NCT02645890: Study to Compare the Safety and Pharmacokinetics of CKD-397
Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Profiles of CKD-397 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Healthy Male Volunteer
Tamsulosin
Tadalafil
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-01-05
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.

Detailed description: A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects

Eligibility criteria: Inclusion Criteria:

1. More than 19 years in Healthy male volunteer
2. Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2
3. Subject who signed on an informed consent form willingly

Exclusion Criteria:

1. Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy)
2. Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy)
3. Aspartate aminotransferase, Alanine aminotransferase \> 2 X upper limit of normal range or eGFR which is calculated by MDRD(Modification of diet in renal disease) \< 60mL/min/1.73m2
4. Continuously taking excessive alcohol(\>210g/week) within 6 months before screening
5. Have received any other investigational drug within 3 months prior to the first dosing
6. Sitting systolic blood pressure ≤ 100mmHg or ≥ 150mmHg, sitting diastolic blood pressure ≤ 60mmHg or ≥ 100mmHg
7. Subject with orthostatic hypotension
8. The history of drug abuse or drug abuse showed a positive for urine drug test
9. Subject who takes inducers or inhibitors of drug metabolizing enzyme within 30 days
10. Cigarette ≥ 20 cigarettes a day for recent 3 months and Subject who cannot stop smoking during clinical trial participation
11. Subject who takes ethical drug or herbal medicine within 2 weeks or over-the-counter drug or vitamins within 1 week
12. Whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing
13. 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.
14. Subject with taking any forms of organic nitrate periodically and/or intermittently.
15. Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
16. Subject with serious history of hypersensitivity to investigational product (including Tadalafil and Tamsulosin) and other medicine (aspirin, antibiotics and so on)
17. Subject who lost sight of one eye by non-arteritic anterior ischemic optic neuropathy (NAION, non-arteritic anterior ischemic optic neuropathy).
18. Subject with genetic problems such as galactose intolerance, fructose intolerance, lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
19. Subject who planned pregnancy during clinical trial and doesn't use trustworthy contraception
20. Subjects who is not able to comply with guidelines described in the protocol.
21. An impossible one who participants in clinical trials by investigator's decision including laboratory test result or another reason

Primary outcomes:
measure: AUC0-t of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary outcomes:
measure: Cmax of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: AUCinf of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: Tmax of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: t1/2 of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: CL/F of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: Vd/F of Tadalafil/ Tamsulosin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Other outcomes:
Locations:
city: Seo-gu
country: Korea, Republic of
facility: Dong A University Hospital
state: Busan
Study officials:
affiliation: 9F, DongA University Hospital Department of clinical pharmacology, #26, Daechingongwon-ro, seo-gu, busan, 49201, KOREA
name: Min Kyu Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: