Hypertension
Conditions
Keywords
CKD-828, Hypertension, Primary Hypertension, Healthy Volunteer, S-Amlodipine, Telmisartan, Amlodipine, Pharmacokinetic, Phase 1
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.
Interventions
DRUGCombination Therapy
Drug: Telmisatan 80mg Tablet, Oral, Once Daily Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily
DRUGCKD-828(FDC)
Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the plasma concentration-time curve (AUC) and Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets. | up to 168 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability. | — |
Countries
South Korea
Outcome results
None listed