To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a day for 6 days.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension; Diseases of the Circulatory System
• Intervention / Treatment: Drug: Atorvastatin; Drug: Telmisartan

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects between the ages of 19 and 55 years
• Subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years
• Healthy Subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
• Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
• Any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy)
• Twofold or more than upper limit of normal range in laboratory test for ALT or AST
• Participating in other clinical trial study within 2 month preceding the first dose of investigational product
• History of significant alcohol abuse or drug abuse within one year prior to the screening
• Whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
• Unwilling or unable to comply with the lifestyle guidelines described in this protocol
• Subjects who are inadequate for this study to participate judged by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1-A; The Part1-A of groups take Telmisartan once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.	Drug: Atorvastatin; Drug: Telmisartan
Experimental: Part1-B; The Part1-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan once a day for 6 days in period 2.	Drug: Atorvastatin; Drug: Telmisartan
Experimental: Part2-A; The Part2-A of groups take Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.	Drug: Atorvastatin; Drug: Telmisartan
Experimental: Part2-B; The Part2-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Atorvastatin once a day for 6 days in period 2.	Drug: Atorvastatin; Drug: Telmisartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCt(0-24)	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
Css,max	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

Secondary Outcome Measures

Outcome Measure	Time Frame
Css,min	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
Css,av	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
Tss,max	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
t1/2	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
CL/F	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
Vd/F	First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

Collaborators and Investigators

• Sponsor: Samil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Atorvastatin; Telmisartan
• Other Study ID Numbers: SI-1307