Clinical trial NCT02579356: To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diseases of the Circulatory System
Essential Hypertension
Lead sponsor: Samil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-19
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUCt(0-24)
timeFrame: 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)
measure: Css,max
timeFrame: 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:
measure: Css,min
timeFrame: 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)
measure: Css,av
timeFrame: 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)
measure: Tss,max
timeFrame: 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)
measure: t1/2
timeFrame: 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)
measure: CL/F
timeFrame: 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)
measure: Vd/F
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
References: