Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chong Kun Dang Pharmaceutical
Age
20–55
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
Have not any congenital or chronic diseases and medical symptom.
Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
Able to participate in the entire trial.
Signed the informed consent form prior to the study participation.
You may not be if
Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
The evidence of acute disease within 28 days prior to the first IP administraion.
Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
Hypersensitivity Telmisartan or Amlodipine.
SBP\<90mmHg or DBP\<50mmHg.
Abnormal laboratory result(s): AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit.
A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
Diet(Especially, grapefruit juice-within 7 days prior to the first IP administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
Donated whole blood within 60 days prior to the first IP administraion.
Participated in the other clinical trials within 90days prior to the first IP administraion.
Medicine within 10 days prior to the first IP administraion? Does the medication affect this trial.
Appropriate for the trial judging from principal investigator.
Clareo Health | CKD-828 (40/5mg) Pharmacokinetic Study
