NCT03889145
Completed
Phase 1
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
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- Hydrochlorothiazide
- Conditions
- Healthy
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 30
- Primary Endpoint
- AUClast
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
Telmisartan, Amlodipine, Hydrochlorothiazide
Intervention: Hydrochlorothiazide
Telmisartan, Amlodipine
Intervention: Telmisartan 80mg
Telmisartan, Amlodipine
Intervention: Amlodipine10mg
Hydrochlorothiazide
Intervention: Hydrochlorothiazide
Telmisartan, Amlodipine, Hydrochlorothiazide
Intervention: Telmisartan 80mg
Telmisartan, Amlodipine, Hydrochlorothiazide
Intervention: Amlodipine10mg
Outcomes
Primary Outcomes
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)]
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)]
Secondary Outcomes
- Tmax(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)])
- AUCinf(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)])
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