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
DRUGCKD-828(FDC)
Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily
DRUGCombination Therapy
Drug: Telmisatan 80mg Tablet, Oral, Once Daily Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
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. * 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
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 hous postdose |
Secondary
| Measure | Time frame |
|---|---|
| Tmax and t1/2 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 |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 22days |
Outcome results
None listed