CKD-828(80/2.5mg) Pharmacokinetic Study

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: CKD-828(FDC)

Drug: Combination Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01246193

130HPS10C

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

65 patients

Sex

All

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.
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.