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CKD-330 Drug-Drug Interaction Study (Candesartan) (CKD-330(C))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064621
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CKD-330 Drug-Drug Interaction Study (Candesartan)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Candesartan 32mg
    Candesartan 32mg 1T, PO, QD for 9days
    Other Name: Atacand Tab. 32mg
  • Drug: Candesartan 32mg/Amlodipine 10mg
    Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
    Other Name: Atacand Tab. 32mg/Norvasc Tab. 10mg
Study Arms  ICMJE
  • Experimental: C(Candesartan 32mg)
    Candesartan 32mg 1T, PO, QD for 9days
    Intervention: 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
    Intervention: Drug: Candesartan 32mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064621
Other Study ID Numbers  ICMJE 144HPS13013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyun-Seop Bae, Professor Asan Medical Center
PRS Account Chong Kun Dang Pharmaceutical
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP