CKD-828(80/2.5mg) Pharmacokinetic Study

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Amlodipine; Telmisartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.