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

NCT02579356 | Completed Phase 1

• 1 other identifier: SI-1307
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diseases of the Circulatory System; Essential Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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)

Study Arms (4)

Part1-A

EXPERIMENTAL

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: Telmisartan; Drug: Atorvastatin

Part1-B

EXPERIMENTAL

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: Telmisartan; Drug: Atorvastatin

Part2-A

EXPERIMENTAL

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: Telmisartan; Drug: Atorvastatin

Part2-B

EXPERIMENTAL

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: Telmisartan; Drug: Atorvastatin

Interventions

Telmisartan DRUG

Part1-A; Part1-B; Part2-A; Part2-B

Atorvastatin DRUG

Part1-A; Part1-B; Part2-A; Part2-B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chonbuk National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Telmisartan; Atorvastatin

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

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; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heptanoic Acids; Fatty Acids; Lipids

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: October 13, 2015
• First Posted: October 19, 2015
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

KR (1)