Overview

CKD-828 (80/5mg) Pharmacokinetic Study

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
Male
Summary
A randomized, open-label, single-dose, two-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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Treatments:
Amlodipine
Telmisartan
Criteria
Inclusion Criteria:

- A healthy volunteer between 20 and 55 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