Clinical Trial to Evaluate Pharmacokinetic Profiles and Safety Between CKD-385 and D935 in Healthy Volunteers

NCT03748212 | Unknown Phase 1

• 1 other identifier: 188BE18024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers

Conditions

Hypertension

Keywords

Hypertension; Chronic stable angina; Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• AUCt of Carvedilol

  Area under the plasma concentration of Carvedilol verses time curve from time zero to time of last quantifiable concentration

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

• Cmax of Carvedilol

  Maximum plasma concentration of Carvedilol

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

Secondary Outcomes (5)

• AUCinf of Carvedilol

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

• Tmax of Carvedilol

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

• t1/2 of Carvedilol

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

• CL/F of Carvedilol

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

• Vd/F of Carvedilol

  Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

Study Arms (2)

Group 1

ACTIVE COMPARATOR

D935 Cap. 1T

Drug: D935 Cap. 1T

Group 2

EXPERIMENTAL

CKD-385 Tab. 1T

Drug: CKD-385 Tab. 1T

Interventions

D935 Cap. 1T DRUG

single oral administration under fed condition

Also known as: D935

Group 1

CKD-385 Tab. 1T DRUG

single oral administration under fed condition

Also known as: CKD-385

Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy adult aged over 19 at the time of screening
• Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²
• Subject who has no congenital or chronic disease within the last 3 years and no medical symptoms or signs as a result of medical examination
• Suitable subject who is determined at the time of screening by examiners according to the characteristics of the medicine such as hematology test, blood chemistry test, urine test, virus / bacteriological test, vital signs, electrocardiogram test
• Subject who signed the written consent form approved by Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to participation of the clinical trial
• Subject who has the ability and willingness to participate in the clinical trial

You may not qualify if:

• Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
• Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
• Subject who shows the following values as a result of laboratory tests
• \*ALT or AST \> 2 times upper limit of normal range
• Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
• Subject who smokes more than one pack of cigarette a day within 6 months of screening
• Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug
• Subject who conform to the specific items below
• systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
• Severe bradycardia (less than 50 beats/minute)
• Subject who has significant alcohol abuse or drug abuse within a year of screening
• Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
• Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
• Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
• Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension; Angina, Stable; Heart Failure

Interventions

D 935

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyung-Ho Jang

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung-Ho Jang

CONTACT

+82-63-259-3500; khjang@jbcp.kr

Min-Gul Kim

CONTACT

mgkim@jbcp.kr

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: November 18, 2018
• First Posted: November 20, 2018
• Study Start: October 24, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 31, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)