CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: Combination Therapy

Drug: CKD-828(FDC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01352689

130HPS11K

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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<SBP or DBP<50mmHg, 100mmHg<DBP.
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