Clinical trial NCT02064556: CKD-330 Drug-Drug Interaction Study (Amlodipine)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: AUCτ,ss of Amlodipine
timeFrame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
measure: Cmax,ss of Amlodipine
timeFrame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
Secondary outcomes:
measure: Tmax,ss of Amlodipine
timeFrame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, Professor
role: PRINCIPAL_INVESTIGATOR
References: