CKD-330 Drug-Drug Interaction Study (Candesartan)

NCT ID: NCT02064621

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-08-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C(Candesartan 32mg)

Candesartan 32mg 1T, PO, QD for 9days

Group Type: EXPERIMENTAL

Candesartan 32mg/Amlodipine 10mg

Intervention Type: DRUG

Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days

B(Candesartan 32mg/Amlodipine 10mg)

Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days

Group Type: EXPERIMENTAL

Candesartan 32mg

Intervention Type: DRUG

Candesartan 32mg 1T, PO, QD for 9days

Interventions

Candesartan 32mg

Candesartan 32mg 1T, PO, QD for 9days

Intervention Type: DRUG

Candesartan 32mg/Amlodipine 10mg

Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days

Intervention Type: DRUG

Other Intervention Names

Atacand Tab. 32mg; Atacand Tab. 32mg/Norvasc Tab. 10mg

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyun-Seop Bae, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

144HPS13013

Identifier Type: -

Identifier Source: org_study_id