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

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

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hypertrophy (BPH)
• Intervention / Treatment: Drug: CKD-397

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan
    • Seo-gu, Busan, Korea, Republic of, 602-715
      • Dong-A University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group; Period 1: CKD-397 1T single oral administration under fasting condition; Period 2: CKD-397 1T single oral administration under fed condition (high fat meals)	Drug: CKD-397; CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals); Other Names: Tamsulosin HCl/Tadalafil 0.2/5mg; HARNAL-D Tab. 0.2mg + Cendom® Tab. 5mg
Experimental: B group; Period 1: CKD-397 1T single oral administration under fed condition (high fat meals); Period 2: CKD-397 1T single oral administration under fasting condition	Drug: CKD-397; CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals); Other Names: Tamsulosin HCl/Tadalafil 0.2/5mg; HARNAL-D Tab. 0.2mg + Cendom® Tab. 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min Kyu Park, MD, PhD, Domg-A University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tadalafil; Tamsulosin
• Other Study ID Numbers: 150FDI15031