CKD-828 Drug Interaction Study (S-amlodipine)
CKD-828 Drug Interaction Study (S-amlodipine)
The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of
 S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine
 monotherapy.
Inclusion Criteria:

 -  Between 20 aged and 50 aged in healthy males

 -  Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening

 -  100mmHg ≤ sit SBP < 140mmHg and 60mmHg ≤ sit DBP < 90mmHg and 50 per/min ≤ Pulse rate
 < 95 per/min

 -  AST, ALT, Total bilirubin < UNL x 1.5

 -  Signed the informed consent from prior to the study participation

 Exclusion Criteria:

 -  Have history of significant hepatic, renal, gastrointestinal, pulmonary,
 musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases

 -  Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or
 surgery(except for Appendectomy, Hernia repair) affected by the absorption of
 medications

 -  galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption

 -  Hypersensitivity reactions to drugs or clinically significant hypersensitivity
 reactions in the history of telmisartan or Amlodipine

 -  drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug
 on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines,
 THC(cannabinoids), methadone etc.

 -  Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC
 within 7 days before the beginning of study treatment

 -  unusual diet affected by the absorption, distribution, metabolism, excretion of
 medications

 -  Subject who treated with any investigational drugs within 90 days before the beginning
 of study treatment

 -  Previously donate whole blood within 60 days or component blood within 30 days or
 transfusion within 30 days

 -  Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates
 etc.) within 30 days

 -  A heavy caffeine consumer (caffeine > 5 units/day)

 -  A heavy alcohol consumer (alcohol > 21 units/week, 1 unit=pure alcohol 10mL) or cannot
 stop drinking

 -  A heavy smoker (cigarette > 20 cigarettes per day)

 -  Positive for Hepatitis B, Hepatitis C, HIV or syphilis

 -  An impossible one who participates in clinical trial by investigator's decision
 including laboratory test result, EKG result