CKD-330 Drug-Drug Interaction Study (Amlodipine)
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Amlodipine 10mg (Drug); Amlodipine 10mg/Candesartan 32mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Chong Kun Dang Pharmaceutical Official(s) and/or principal investigator(s): Kyun-Seop Bae, Professor, Principal Investigator, Affiliation: Asan Medical Center
Summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of
Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine
monotherapy.
Clinical Details
Official title: A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine Monotherapy in Healthy Male Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUCτ,ss of AmlodipineCmax,ss of Amlodipine
Secondary outcome: Tmax,ss of Amlodipine
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of
Additional Information
Starting date: May 2014
Last updated: August 13, 2014
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