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

NCT02615782 | Completed Phase 1

• 1 other identifier: 150FDI15031
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Benign Prostatic Hypertrophy (BPH)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (2)

A group

EXPERIMENTAL

1. Period 1: CKD-397 1T single oral administration under fasting condition 2. Period 2: CKD-397 1T single oral administration under fed condition (high fat meals)

Drug: CKD-397

B group

EXPERIMENTAL

1. Period 1: CKD-397 1T single oral administration under fed condition (high fat meals) 2. Period 2: CKD-397 1T single oral administration under fasting condition

Drug: CKD-397

Interventions

CKD-397 DRUG

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

Also known as: Tamsulosin HCl/Tadalafil 0.2/5mg, HARNAL-D Tab. 0.2mg + Cendom® Tab. 5mg

A group; B group

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subject older than 19 years at the time of screening.
• Subjects who BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
• Subjects who signed the informed consent form after understanding fully to hear a detailed explanation in the clinical trial

You may not qualify if:

• 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)
• Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
• Subjects who show AST or AST \> 2 times upper limit of normal range or eGFR \< 60 mL/min/1.73m2
• Subjects who drink Alcohol \> 210g/week within 6 months prior to the screening.
• Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
• Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening
• Subjects who have orthostatic hypotension
• Subjects who have history of drug abuse or drug abuse positive at screening
• Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
• Smoker ( ≥ 20cigarettes/day)
• Subjects who takes ETC or herb medicine within two weeks or OTC or vitamin supplement within 1 week before the first IP administration
• 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
• 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
• Subjects who take organic nitrate medicine regularly or intermittently
• Patients with genetic degenerative retinal disease including retinitis pigmentosa

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Dong-A University Hospital

Seo-gu, Busan, 602-715, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Min Kyu Park, MD, PhD

  Domg-A University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 26, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

KR (1)