CKD-828(80/2.5mg) Pharmacokinetic Study

NCT ID: NCT01246193

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2010-12-31

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
• 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

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: ACTIVE_COMPARATOR

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.
• 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.

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

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Clincal Research Department

Principal Investigators

Eunyoung Kim

Role: PRINCIPAL_INVESTIGATOR

Inje Unuversity Pusan Paik Hospital

Locations

Inje Unuversity Pusan Paik Hospital

Pusan, , South Korea

Countries

South Korea

Other Identifiers

130HPS10C

Identifier Type: -

Identifier Source: org_study_id