- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02064621
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
Intervention / Treatment
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
-
-
Songpa-gu
-
Seoul, Songpa-gu, Korea, Republic of
- Asan Medical Center
-
-
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:
- 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.
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:
|
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:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Candesartan
- Candesartan cilexetil
Other Study ID Numbers
- 144HPS13013
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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