CKD-828 (40/5mg) Pharmacokinetic Study

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: CKD-828; Drug: Combination Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340131

130HPS10G

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: 68 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.
• 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.
• Appropriate for the trial judging from principal investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

CKD-828(Fixed Dose Combination)

Experimental group

Description:

Single oral dose of a FDC tablet consisting of Telmisatan 40mg/S-Amlodipine 5mg Intervention

Treatment:

Drug: CKD-828

Free combination Therapy

Active Comparator group

Description:

Co-administration of single oral doses of a 40mg tablet of Telmisatan and a 5 mg tablet of S-Amlodipine

Treatment:

Drug: Combination Therapy