A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide

NCT03889145 | Completed Phase 1

• 1 other identifier: ID-TAH-1301
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUClast

  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

  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 (2)

• 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)]

• 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)]

Other Outcomes (2)

• t1/2

  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

  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)]

Study Arms (3)

Telmisartan, Amlodipine

ACTIVE COMPARATOR

Drug: Telmisartan 80mg; Drug: Amlodipine10mg

Hydrochlorothiazide

ACTIVE COMPARATOR

Drug: Hydrochlorothiazide

Telmisartan, Amlodipine, Hydrochlorothiazide

EXPERIMENTAL

Drug: Telmisartan 80mg; Drug: Amlodipine10mg; Drug: Hydrochlorothiazide

Interventions

Telmisartan 80mg DRUG

Telmisartan 80mg

Telmisartan, Amlodipine; Telmisartan, Amlodipine, Hydrochlorothiazide

Amlodipine10mg DRUG

Amlodipine 10mg

Telmisartan, Amlodipine; Telmisartan, Amlodipine, Hydrochlorothiazide

Hydrochlorothiazide DRUG

Hydrochlorothiazide 25mg

Hydrochlorothiazide; Telmisartan, Amlodipine, Hydrochlorothiazide

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Related Publications (1)

• Moon SJ, Jeon JY, Yu KS, Kim MG. Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects. Clin Ther. 2019 Nov;41(11):2273-2282. doi: 10.1016/j.clinthera.2019.08.020. Epub 2019 Sep 26.

  PMID: 31564513 DERIVED

MeSH Terms

Interventions

Telmisartan; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

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 19, 2019
• First Posted: March 26, 2019
• Study Start: December 19, 2013
• Primary Completion: February 19, 2014
• Study Completion: February 19, 2014
• Last Updated: March 26, 2019

Record last verified: 2019-03