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CompletedNCT02645890CKD-397Updated Jan 12, 2016

Study to Compare the Safety and Pharmacokinetics of CKD-397

A Phase 1 interventional study of CKD-397 and TD+TM in Benign Prostatic Hyperplasia, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-12.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years and older
Sex
Male
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Benign Prostatic Hyperplasia

Keywords

  • Benign Prostatic Hyperplasia
  • Healthy Male Volunteer
  • Tamsulosin
  • Tadalafil
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 36 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    CKD-397

    Tadalafil/ Tamsulosin Fixed dose combination

    Drug: CKD-397

  • Experimental
    TD+TM

    Tadalafil/ Tamsulosin Coadministration

    Drug: TD+TM

Interventions

  • DrugCKD-397

    Arm A:Tamsulosin/ Tadalafil Fixed dose combination

    Also known as: Arm A

  • DrugTD+TM

    Arm B: Tamsulosin/ Tadalafil Coadministration

    Also known as: Arm B

06

What researchers measure

Primary outcomes

  1. AUC0-t of Tadalafil/ Tamsulosin

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

Secondary outcomes

  1. Cmax of Tadalafil/ Tamsulosin

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

  2. AUCinf of Tadalafil/ Tamsulosin

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

  3. Tmax of Tadalafil/ Tamsulosin

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

  4. t1/2 of Tadalafil/ Tamsulosin

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

  5. CL/F of Tadalafil/ Tamsulosin

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

  6. Vd/F of Tadalafil/ Tamsulosin

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

07

Study locations

1 site
  • Dong A University Hospital
    Seo-gu, Busan 49201, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02645890
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jan 5, 2016
Start date
Nov 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 12, 2016

Study contacts

Min Kyu Park, MD, PhD
principal investigator · 9F, DongA University Hospital Department of clinical pharmacology, #26, Daechingongwon-ro, seo-gu, busan, 49201, KOREA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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