CKD-828 (80/5mg) Pharmacokinetic Study

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: CKD-828; Drug: Telmisartan; Drug: S-amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02250833

130HPS14006

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

69 participants in 2 patient groups

CKD-828(Fixed Dose Combination)

Experimental group

Description:

FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg

Treatment:

Drug: CKD-828

Combination Therapy

Active Comparator group

Description:

Coadministration of Telmisartan 80mg and S-amlodipine 5mg

Treatment:

Drug: S-amlodipine

Drug: Telmisartan