Study to Compare the Safety and Pharmacokinetics of CKD-397

NCT ID: NCT02645890

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2015-12-31

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

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-397

Tadalafil/ Tamsulosin Fixed dose combination

Group Type: ACTIVE_COMPARATOR

CKD-397

Intervention Type: DRUG

Arm A:Tamsulosin/ Tadalafil Fixed dose combination

TD+TM

Tadalafil/ Tamsulosin Coadministration

Group Type: EXPERIMENTAL

TD+TM

Intervention Type: DRUG

Arm B: Tamsulosin/ Tadalafil Coadministration

Interventions

CKD-397

Arm A:Tamsulosin/ Tadalafil Fixed dose combination

Intervention Type: DRUG

TD+TM

Arm B: Tamsulosin/ Tadalafil Coadministration

Intervention Type: DRUG

Other Intervention Names

Arm A; Arm B

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Kyu Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

9F, DongA University Hospital Department of clinical pharmacology, #26, Daechingongwon-ro, seo-gu, busan, 49201, KOREA

Locations

Dong A University Hospital

Seo-gu, Busan, South Korea

Countries

South Korea

Other Identifiers

150BPH15022

Identifier Type: -

Identifier Source: org_study_id