CKD-330 Drug-Drug Interaction Study (Candesartan)

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan 32mg; Drug: Candesartan 32mg/Amlodipine 10mg

• Registration Number: NCT02064621
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B(Candesartan 32mg/Amlodipine 10mg)	Candesartan 32mg	Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
C(Candesartan 32mg)	Candesartan 32mg/Amlodipine 10mg	Candesartan 32mg 1T, PO, QD for 9days

Primary Outcome Measures

Name	Time	Method
AUCτ,ss of Candesartan	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	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

Name	Time	Method
Tmax,ss of Candesartan	1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of