- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889145
A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide
March 21, 2019 updated by: IlDong Pharmaceutical Co Ltd
A Randomized, Open-label, Single Dose, 3-way Crossover Study to Evaluate the Drug-drugs Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs interaction between Telmisartan, Amlodipine and Hydrochlorothiazide in healthy male volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male volunteers aged 20 to 55 years
- Subjects who have 17.5 ~ 30.5 kg/m2 body mass index (BMI) and body weight that is more than 55kg
- Subjects who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination.
- Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as electrocardiography(ECG) test.
- Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital Institutional Review Board(IRB).
Exclusion Criteria:
- Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who involved in other clinical trials within two months before the first dose medication characters.
- Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening
- Subjects who had alcohol or drug abuse within one year before the screening
- Subjects who took medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
- Subjects who smoke 20 cigarettes or more a day
- Subjects who take medicine within 10 days before the first investigational product administration.
- Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
- Subject who can increase risk due to clinical test and administration of drugs or has severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- Subjects with serious history of hypersensitivity or allergy to investigational product.
- Subjects with severe hepatic impairment or Gallbladder Disease.
- Subject with hereditary angioedema or a history of angioedema when treated with ACE(Angiotensin-Converting enzyme) inhibitor or ARB(Angiotensin II Receptor Blocker) therapy
- Subjects who take combination medication with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
- Subjects with severe hepatic impairment
- Subjects who have severe aortic stenosis
- Subjects with acute or severe renal failure
- Subjects with hyponatremia or hypokalemia
- Subjects with Addison's disease
- Subjects with hypercalcemia
- Subjects who have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects who are unwilling or unable to comply with the Lifestyle guidelines described in this protocol
- Subject who are inadequate for this study to participate judged by investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hydrochlorothiazide
|
Hydrochlorothiazide 25mg
|
Active Comparator: Telmisartan, Amlodipine
|
Telmisartan 80mg
Amlodipine 10mg
|
Experimental: Telmisartan, Amlodipine, Hydrochlorothiazide
|
Hydrochlorothiazide 25mg
Telmisartan 80mg
Amlodipine 10mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUClast
Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Cmax
Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCinf
Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Tmax
Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
t1/2
Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
CL/F
Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2013
Primary Completion (Actual)
February 19, 2014
Study Completion (Actual)
February 19, 2014
Study Registration Dates
First Submitted
March 19, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 21, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Amlodipine
- Hydrochlorothiazide
- Telmisartan
Other Study ID Numbers
- ID-TAH-1301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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