CKD-828 (80/5mg) Pharmacokinetic Study (CKD-828)

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: CKD-828; Drug: Telmisartan; Drug: S-amlodipine

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • samdeok-dong, 2-ga 50 Jung-gu
    • Daegu, samdeok-dong, 2-ga 50, samdeok-dong, 2-ga 50 Jung-gu, Korea, Republic of, 700-721
      • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CKD-828(Fixed Dose Combination); FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg	Drug: CKD-828; Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period); Other Names: Telminuvo
ACTIVE_COMPARATOR: Combination Therapy; Coadministration of Telmisartan 80mg and S-amlodipine 5mg	Drug: Telmisartan; - Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period); Other Names: Micardis; Drug: S-amlodipine; - S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period); Other Names: Anydipine s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.	up to 144 hours post dose
AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.	up to 144 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.		up to 144 hours post dose
t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.		up to 144 hours post dose
AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.		up to 144 hours post dose
Number of participants with adverse events	- Adverse Event monitoring	up to 59days post dose

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (ESTIMATE): February 9, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Hypertension; Telmisartan; Pharmacokinetic; CKD-828; S-amlodipine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan
• Other Study ID Numbers: 130BE15002