A Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 in Healthy Male Subjects

Benign Prostatic Hypertrophy (BPH) Clinical Trial

Official title:

A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 After a Single Oral Dose in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615782
• Other study ID #: 150FDI15031
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2015
• Last updated: August 8, 2017
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects

Description:

To healthy male subjects of sixteen(16), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.

Treatment A: CKD-397 1T under Fasting condition Treatment B: CKD-397 1T under Fed condition (high fat meals). Pharmacokinetic blood samples are collected up to 72hrs. Safety and pharmacokinetic are assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Healthy male subject older than 19 years at the time of screening.

2. Subjects who BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg

3. Subjects who signed the informed consent form after understanding fully to hear a detailed explanation in the clinical trial

Exclusion Criteria:

1. Subjects who have 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. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.

3. Subjects who show AST or AST > 2 times upper limit of normal range or eGFR < 60 mL/min/1.73m2

4. Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.

5. Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.

6. Subjects who show Systolic Blood Pressure =100 or =150 mmHg or Diastolic Blood Pressure =60 or =100 mmHg at screening

7. Subjects who have orthostatic hypotension

8. Subjects who have history of drug abuse or drug abuse positive at screening

9. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.

10. Smoker ( = 20cigarettes/day)

11. Subjects who takes ETC or herb medicine within two weeks or OTC or vitamin supplement within 1 week before the first IP administration

12. Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing or receive blood transfusion within 1month prior to the first dosing

13. Subjects 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. Subjects who take organic nitrate medicine regularly or intermittently

15. Patients with genetic degenerative retinal disease including retinitis pigmentosa

16. Subjects who have hypersensitivity to medicines including tadalafil/tamsulosin component or any other medicines(aspirin, antibiotics etc.) or medical history of clinically significant hypersensitivity

17. Patients who lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy(NAION)

18. Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

19. Subjects who use a trustworthy method of contraception

20. Subjects who is not able to comply with guidelines described in the protocol

21. Subjects who is determined by investigator's decision including laboratory test result or another reason as unsuitable for clinical trial participation

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy (BPH)
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Drug:
• CKD-397
CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)

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	AUClast of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Primary	Cmax of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Secondary	AUCinf of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Secondary	Tmax of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Secondary	t1/2 of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Secondary	CL/F of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Secondary	Vd/F of Tadalafil and Tamsulosin		0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs