CKD-330 Drug-Drug Interaction Study (Amlodipine)

NCT02064556 | Completed Phase 1 DMC

• 1 other identifier: 144HPS13012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss of Amlodipine

  1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h

• Cmax,ss of Amlodipine

  1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h

Secondary Outcomes (1)

• Tmax,ss of Amlodipine

  1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h

Study Arms (2)

A(Amlodipine 10mg)

EXPERIMENTAL

Amlodipine 10mg 1T, PO, QD for 9days

Drug: Amlodipine 10mg/Candesartan 32mg

B(Amlodipine 10mg/Candesartan 32mg)

EXPERIMENTAL

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

Drug: Amlodipine 10mg

Interventions

Amlodipine 10mg DRUG

Amlodipine 10mg 1T, PO, QD for 9days

Also known as: Norvasc Tab. 10mg

B(Amlodipine 10mg/Candesartan 32mg)

Amlodipine 10mg/Candesartan 32mg DRUG

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

Also known as: Norvasc Tab. 10mg/Atacand Tab. 32mg

A(Amlodipine 10mg)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• mmHg ≤ sitting SBP \<140 mmHg
• mmHg ≤ sitting DBP \< 90 mmHg
• bpm ≤ Pulse \< 95 bpm
• Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; candesartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kyun-Seop Bae, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

KR (1)