CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

NCT ID: NCT01352689

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-05-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-828(Fixed Dose Combination)

Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg

Group Type: EXPERIMENTAL

CKD-828(FDC)

Intervention Type: DRUG

Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily

Free combination Therapy

Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine

Group Type: EXPERIMENTAL

Combination Therapy

Intervention Type: DRUG

Drug: Telmisatan 80mg Tablet, Oral, Once Daily

Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily

Interventions

CKD-828(FDC)

Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily

Intervention Type: DRUG

Combination Therapy

Drug: Telmisatan 80mg Tablet, Oral, Once Daily

Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily

Intervention Type: DRUG

Eligibility 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<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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Clincal Research Department

Other Identifiers

130HPS11K

Identifier Type: -

Identifier Source: org_study_id