CKD-828 (80/5mg) Pharmacokinetic Study

NCT02250833 | Completed Phase 1

• 1 other identifier: 130HPS14006
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; CKD-828; Telmisartan; S-amlodipine; Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

  up to 168 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 168 hours post dose

Secondary Outcomes (4)

• Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.

  up to 168 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 168 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 168 hours post dose

• Number of participants with adverse events

  up to 31days post dose

Study Arms (2)

CKD-828(Fixed Dose Combination)

EXPERIMENTAL

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

Drug: CKD-828

Combination Therapy

ACTIVE COMPARATOR

Coadministration of Telmisartan 80mg and S-amlodipine 5mg

Drug: Telmisartan; Drug: S-amlodipine

Interventions

CKD-828 DRUG

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

Also known as: Telminuvo

CKD-828(Fixed Dose Combination)

Telmisartan DRUG

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

Also known as: Micardis

Combination Therapy

S-amlodipine DRUG

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

Also known as: Anydipine s

Combination Therapy

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu, 700-721, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; levamlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Young-Ran Yoon

  Kyungpook National University Hospital Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

KR (1)