Status:
COMPLETED
CKD-828(80/2.5mg) Pharmacokinetic Study
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- A pregnant or nursing women who does not use medically acceptable birth control.
- Appropriate for the trial judging from principal investigator.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01246193
Start Date
November 1 2010
End Date
December 1 2010
Last Update
January 19 2011
Active Locations (1)
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1
Inje Unuversity Pusan Paik Hospital
Pusan, South Korea