CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Take oriental medicine inside St John's Wort or metabolism of CYP3A4 enzyme or inhibite the CYP enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, HIV protease inhibitor)

• 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, 150mmHg- Abnormal laboratory result(s): AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit.

• Creatinine Clearance<80mL/min

• Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, nervous system or hyperpotassemia (Past history or present)

• History of drug abuse(sleeping tablet, nucleus action painkiller, an opiate or psychotrope etc the central nervous system drug)or showed a positive for the urine screening exam.

• any abnormal diet which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. drinking grapefruit juice(more than 1L per a day) during 7 weeks prior to the first IP administration.)

• 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.

• Previously donate whole blood within 60 days or component blood within 30 days prior to the first IP administraion.

• Medication within 7 days in the first IP administraion professional medical, medicine, OTC taking

• Participated in the other clinical trials within 60days prior to the first IP administraion.

• An impossible one who participates in clinical trial by investigator's decision