None listed
Conditions
Interventions
Drug : The study design was composed of 2 parts, 2-way crossover and single dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 21 days between
Sponsors
Samil Pharm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: * Healthy male subjects between the ages of 19 and 55 years, inclusive * Subject who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years * Subject is healthy (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
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 Alanine Transaminase or Aspartate Transaminase * Participating in other clinical trial study within 2 months 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 2 weeks 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 * Subject who are inadequate for this study to partcipate judged by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast, Cmax of telmisartan and amlodipine;AUClast, Cmax of hydrochlorothiazide | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, t1/2, CL/F, Vd/F of telmisartan and amlodipine;AUCinf, Tmax, t1/2, CL/F, Vd/F of hydrochlorothiazide | — |
Countries
Korea, Republic of
Contacts
Public ContactJiYoung Jeon
Chonbuk National University Hospital
Outcome results
None listed