Study to Compare the Safety and Pharmacokinetics of CKD-397

NCT02645890 | Completed Phase 1

• 1 other identifier: 150BPH15022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; Healthy Male Volunteer; Tamsulosin; Tadalafil

Outcome Measures

Primary Outcomes (1)

• AUC0-t of Tadalafil/ Tamsulosin

  0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Secondary Outcomes (6)

• Cmax of Tadalafil/ Tamsulosin

  0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

• AUCinf of Tadalafil/ Tamsulosin

  0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

• Tmax of Tadalafil/ Tamsulosin

  0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

• t1/2 of Tadalafil/ Tamsulosin

  0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

• CL/F of Tadalafil/ Tamsulosin

  0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Study Arms (2)

CKD-397

ACTIVE COMPARATOR

Tadalafil/ Tamsulosin Fixed dose combination

Drug: CKD-397

TD+TM

EXPERIMENTAL

Tadalafil/ Tamsulosin Coadministration

Drug: TD+TM

Interventions

CKD-397 DRUG

Arm A:Tamsulosin/ Tadalafil Fixed dose combination

Also known as: Arm A

CKD-397

TD+TM DRUG

Arm B: Tamsulosin/ Tadalafil Coadministration

Also known as: Arm B

TD+TM

Eligibility Criteria

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

You may qualify if:

• More than 19 years in Healthy male volunteer
• Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2
• Subject who signed on an informed consent form willingly

You may not qualify if:

• Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy)
• Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy)
• 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
• Continuously taking excessive alcohol(\>210g/week) within 6 months before screening
• Have received any other investigational drug within 3 months prior to the first dosing
• Sitting systolic blood pressure ≤ 100mmHg or ≥ 150mmHg, sitting diastolic blood pressure ≤ 60mmHg or ≥ 100mmHg
• Subject with orthostatic hypotension
• The history of drug abuse or drug abuse showed a positive for urine drug test
• Subject who takes inducers or inhibitors of drug metabolizing enzyme within 30 days
• Cigarette ≥ 20 cigarettes a day for recent 3 months and Subject who cannot stop smoking during clinical trial participation
• Subject who takes ethical drug or herbal medicine within 2 weeks or over-the-counter drug or vitamins within 1 week
• Whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing
• 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.
• Subject with taking any forms of organic nitrate periodically and/or intermittently.
• Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Dong A University Hospital

Seo-gu, Busan, 49201, 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

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

  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: December 21, 2015
• First Posted: January 5, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

KR (1)