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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579356
• Other study ID #: SI-1307
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2015
• Last updated: October 15, 2015
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: Samil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diseases of the Circulatory System
• Essential Hypertension
• Hypertension

Intervention

Drug:
• Telmisartan

• Atorvastatin

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No