To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunt… (NCT02579356) | Clinical Trial Compass
CompletedPhase 1
To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers
South Korea48 participantsStarted 2014-05
Plain-language 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.
Who can participate
Age range19 Years – 55 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
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)
2
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)