Study to Compare the Safety and Pharmacokinetics of CKD-397

Benign Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645890
• Other study ID #: 150BPH15022
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2015
• Last updated: January 11, 2016
• Start date: November 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• CKD-397
Arm A:Tamsulosin/ Tadalafil Fixed dose combination
• TD+TM
Arm B: Tamsulosin/ Tadalafil Coadministration

Locations

Country	Name	City	State
Korea, Republic of	Dong A University Hospital	Seo-gu	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No
Secondary	Cmax of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No
Secondary	AUCinf of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No
Secondary	Tmax of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No
Secondary	t1/2 of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No
Secondary	CL/F of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No
Secondary	Vd/F of Tadalafil/ Tamsulosin		0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours	No