Completed
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
What is being tested
Candesartan32mg
+ Amlodipine10mg
+ Candesartan32mg
Drug
Who is being recruted
Cardiovascular Diseases
+ Vascular Diseases
+ Hypertension
From 20 to 45 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: December 2012
Summary
Principal SponsorHanAll BioPharma Co., Ltd.
Last updated: April 20, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorHanAll BioPharma Co., Ltd.
Last updated: April 20, 2025
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 20 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesVascular DiseasesHypertension
Criteria
2 inclusion criteria required to participate
Healthy male, Age 20 to 45
Subject must be willing and able to provide written informed consent to the study
5 exclusion criteria prevent from participating
History of any significant gastrointestinal system and surgery of gastrointestinal
History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic
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
Other condition which in the opinion of the investigator preclude endrollment into the study
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorCandesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
Group II
Active ComparatorCandesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Chungnam national university hospital,clinical trial center
Daejeon, South KoreaOpen Chungnam national university hospital,clinical trial center in Google MapsCompletedOne Study Center