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CompletedNCT02064621CKD-330(C)Updated Sep 3, 2014

CKD-330 Drug-Drug Interaction Study (Candesartan)

A Phase 1 interventional study of Candesartan 32mg and Candesartan 32mg/Amlodipine 10mg in Hypertension, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-03.

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Candesartan between free combination of Candesartan and Amlodipine and Candesartan monotherapy.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 24 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension 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
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
  2. Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
  3. When volunteer in screening, Must include under the items.

    1. 100 mmHg ≤ sitting SBP \<140 mmHg
    2. 60 mmHg ≤ sitting DBP \< 90 mmHg
    3. 45 bpm ≤ Pulse \< 95 bpm
  4. Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion criteria

Exclusion Criteria:

  1. A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
  2. Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
  3. The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
  4. The history of drug abuse or drug abuse showed a positive for urine drug test.
  5. Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
  6. Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
  7. Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
  8. A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month)
  9. A heavy smoker(cigarette>10cigarettes/day)
  10. The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
  11. Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
  12. Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
  13. The result of 12-lead ECG in screening test is QTc>450msec.
  14. An impossible one who participants in clinical trial 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
24 participants (actual)

Study arms

  • Experimental
    C(Candesartan 32mg)

    Candesartan 32mg 1T, PO, QD for 9days

    Drug: Candesartan 32mg/Amlodipine 10mg

  • Experimental
    B(Candesartan 32mg/Amlodipine 10mg)

    Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days

    Drug: Candesartan 32mg

Interventions

  • DrugCandesartan 32mg

    Candesartan 32mg 1T, PO, QD for 9days

    Also known as: Atacand Tab. 32mg

  • DrugCandesartan 32mg/Amlodipine 10mg

    Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days

    Also known as: Atacand Tab. 32mg/Norvasc Tab. 10mg

06

What researchers measure

Primary outcomes

  1. AUCτ,ss of Candesartan

    Time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h

  2. Cmax,ss of Candesartan

    Time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h

Secondary outcomes

  1. Tmax,ss of Candesartan

    Time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Songpa-gu, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02064621
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Feb 17, 2014
Start date
Jun 2014
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Sep 3, 2014

Study contacts

Kyun-Seop Bae, Professor
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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