Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg
An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers
1 other identifier
interventional
36
1 country
1
Brief Summary
Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hypertension
Started Dec 2012
Typical duration for phase_1 hypertension
1 active site
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
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 20, 2025
February 1, 2014
8 months
March 4, 2013
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part A : AUC, Cmax of Candesartan
Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine
Over a 24-hour sampling period
Secondary Outcomes (2)
PartA: Cmin, tmax, CL/F of Candesartan
Over a 24-hour sampling period
PartB: Cmin, tmax, CL/F of Amlodipine
Over a 24-hour sampling period
Study Arms (2)
PartA: Candesartan, Candesartan + Amolodipine
ACTIVE COMPARATORCandesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
PartB: Amlodipine, Amlodipine+Candesartan
ACTIVE COMPARATORCandesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male, Age 20 to 45
- Subject must be willing and able to provide written informed consent to the study.
You may not qualify if:
- History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
- History of any significant gastrointestinal system and surgery of gastrointestinal.
- History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
- Over 10 tobaccos a day.
- Other condition which in the opinion of the investigator preclude endrollment into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungnam national university hospital,clinical trial center
Daejeon, Chungcheongbul-do, 301-721, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jang Hee Hong, Associate Professor
Chungnam national university hospital, Clinical trial center
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
March 4, 2013
First Posted
March 7, 2013
Study Start
December 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
April 20, 2025
Record last verified: 2014-02