Clinical trial NCT02358824: CKD-828 (80/5mg) Pharmacokinetic Study
Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Hypertension
CKD-828
Telmisartan
S-amlodipine
Pharmacokinetic
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-02-09
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, four-period, two-way, crossover study,

Detailed description: A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.

Eligibility criteria: Inclusion Criteria:

* A healthy volunteer over 20 years old
* More than 50kg and within 20% of ideal body weight
* No any congenital or chronic diseases and medical symptom
* Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* History of relevant hypersensitivity against drug
* Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
* Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin \> 1.5\*ULN)
* SBP \<90mmHg or SBP \>150mmHg
* DBP \<50mmHg or DBP \>100mmHg
* Creatinine clearance \<80mL/min
* A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
* The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
* Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
* Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug

Primary outcomes:
measure: Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
timeFrame: up to 144 hours post dose
measure: AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
timeFrame: up to 144 hours post dose
Secondary outcomes:
measure: Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
timeFrame: up to 144 hours post dose
measure: t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
timeFrame: up to 144 hours post dose
measure: AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
timeFrame: up to 144 hours post dose
measure: Number of participants with adverse events
timeFrame: up to 59days post dose
Other outcomes:
Locations:
city: Daegu, samdeok-dong, 2-ga 50
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: samdeok-dong, 2-ga 50 Jung-gu
Study officials:
affiliation: Kyungpook National University Hospital Clinical Trial Center
name: Young-Ran Yoon
role: PRINCIPAL_INVESTIGATOR
References: