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

September 1, 2014 updated by: Chong Kun Dang Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C(Candesartan 32mg)
Candesartan 32mg 1T, PO, QD for 9days
Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
Other Names:
  • Atacand Tab. 32mg/Norvasc Tab. 10mg
Experimental: B(Candesartan 32mg/Amlodipine 10mg)
Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
Candesartan 32mg 1T, PO, QD for 9days
Other Names:
  • Atacand Tab. 32mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyun-Seop Bae, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 1, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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