CKD-828 (80/5mg) Pharmacokinetic Study

NCT ID: NCT02358824

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-828(Fixed Dose Combination)

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

Group Type: EXPERIMENTAL

CKD-828

Intervention Type: DRUG

Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily

(1arm:2period and 4period, 2arm:1period and 3period)

Combination Therapy

Coadministration of Telmisartan 80mg and S-amlodipine 5mg

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

• Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)

(1arm:1period and 3period, 2arm: 2period and 4period)

S-amlodipine

Intervention Type: DRUG

• S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)

(1arm:1period and 3period, 2arm: 2period and 4period)

Interventions

CKD-828

Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily

(1arm:2period and 4period, 2arm:1period and 3period)

Intervention Type: DRUG

Telmisartan

• Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)

(1arm:1period and 3period, 2arm: 2period and 4period)

Intervention Type: DRUG

S-amlodipine

• S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)

(1arm:1period and 3period, 2arm: 2period and 4period)

Intervention Type: DRUG

Other Intervention Names

Telminuvo; Micardis; Anydipine s

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-Ran Yoon

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital Clinical Trial Center

Locations

Kyungpook National University Hospital

Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu, South Korea

Countries

South Korea

Other Identifiers

130BE15002

Identifier Type: -

Identifier Source: org_study_id