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