Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT03461081

Recruitment Status : Completed

First Posted : March 9, 2018

Last Update Posted : March 12, 2018

Sponsor:

Information provided by (Responsible Party):

Jeil Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers

Condition or disease	Intervention/treatment	Phase
Hypertension With Hyperlipidemia	Drug: telmisartan/amlodipine and atorvastatin	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers
Actual Study Start Date :	May 7, 2017
Actual Primary Completion Date :	July 12, 2017
Actual Study Completion Date :	December 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

MedlinePlus related topics: Drug Reactions Medicines

Drug Information available for: Amlodipine Amlodipine besylate Atorvastatin Atorvastatin calcium Telmisartan Caduet

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group I Period I: administration of telmisartan/Amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days Period II: atorvastatin for 4 days	Drug: telmisartan/amlodipine and atorvastatin Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days
Experimental: Group II Period I: administration of atorvastatin for 4 days Period II: administration of telmisartan/amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days	Drug: telmisartan/amlodipine and atorvastatin Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days

Outcome Measures

Primary Outcome Measures :

AUCτ of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin [ Time Frame: Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours ]
Css,max of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin [ Time Frame: Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 55 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

19~55 years healthy male
The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

Subjects who are allergic to investigational drug.
Subjects who have a medical history which can affect the clinical trial.
Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 70mmHg)
Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461081

Locations

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

Jeil Pharmaceutical Co., Ltd.

More Information

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Responsible Party:	Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT03461081
Other Study ID Numbers:	JLP-1610-101-DDI
First Posted:	March 9, 2018 Key Record Dates
Last Update Posted:	March 12, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Amlodipine Telmisartan Telmisartan amlodipine combination Amlodipine, atorvastatin drug combination Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites	Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists

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