NCT02064621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_1 hypertension

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

February 14, 2014

Last Update Submit

September 1, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

C(Candesartan 32mg)

EXPERIMENTAL

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

Drug: Candesartan 32mg/Amlodipine 10mg

B(Candesartan 32mg/Amlodipine 10mg)

EXPERIMENTAL

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

Drug: Candesartan 32mg

Interventions

Candesartan 32mgDRUG

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

Also known as: Atacand Tab. 32mg
B(Candesartan 32mg/Amlodipine 10mg)
Candesartan 32mg/Amlodipine 10mgDRUG

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

Also known as: Atacand Tab. 32mg/Norvasc Tab. 10mg
C(Candesartan 32mg)

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartancandesartan cilexetilAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic 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

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-02

Locations

KR(1)