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Completed

NCT Number: NCT02064621

CKD-330 Drug-Drug Interaction Study (Candesartan)

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, Songpa-gu, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
  • Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
  • When volunteer in screening, Must include under the items.
  • 100 mmHg ≤ sitting SBP <140 mmHg
  • 60 mmHg ≤ sitting DBP < 90 mmHg
  • 45 bpm ≤ Pulse < 95 bpm
  • Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion criteria

  • A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
  • 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).
  • The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
  • The history of drug abuse or drug abuse showed a positive for urine drug test.
  • 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.
  • Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
  • Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
  • A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month)
  • A heavy smoker(cigarette>10cigarettes/day)
  • The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
  • Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
  • Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
  • The result of 12-lead ECG in screening test is QTc>450msec.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

Treatment and study plan

Candesartan 32mg

Drug

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

Other names: Atacand Tab. 32mg

Candesartan 32mg/Amlodipine 10mg

Drug

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

Other names: Atacand Tab. 32mg/Norvasc Tab. 10mg

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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Candesartan Between Free Combination of Candesartan and Amlodipine and Candesartan Monotherapy in Healthy Male Volunteers

Acronym: CKD-330(C)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2014
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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