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

A Randomized, Open-label, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers

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

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: D935 Cap. 1T; Drug: CKD-385 Tab. 1T

Detailed Description

To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kyung-Ho Jang; Phone Number: +82-63-259-3500; Email: khjang@jbcp.kr
• Study Contact Backup: Name: Min-Gul Kim; Email: mgkim@jbcp.kr

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
    • Contact: Kyung-Ho Jang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A healthy adult aged over 19 at the time of screening
2. Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²
3. 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
4. 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
5. 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
6. Subject who has the ability and willingness to participate in the clinical trial

Exclusion Criteria:

1. 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.)
2. 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

3. Subject who shows the following values as a result of laboratory tests

   *ALT or AST > 2 times upper limit of normal range

4. Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
5. Subject who smokes more than one pack of cigarette a day within 6 months of screening
6. Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug

7. 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)
8. Subject who has significant alcohol abuse or drug abuse within a year of screening
9. Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
10. 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.
11. 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
12. Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
13. Subject who does not consent to reliable contraception during the entire period of clinical trial and until 7th day of administration of clinical trial drug.
14. Subject who is not able to consume high-fat meal provided during the clinical trial
15. Any other subject who is decided by investigators to be ineligible in clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; D935 Cap. 1T	Drug: D935 Cap. 1T; single oral administration under fed condition; Other Names: D935
Experimental: Group 2; CKD-385 Tab. 1T	Drug: CKD-385 Tab. 1T; single oral administration under fed condition; Other Names: CKD-385

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of Carvedilol	Area under the plasma concentration of Carvedilol versus time curve from time zero to time infinity	Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Tmax of Carvedilol	Time to maximum concentration of Carvedilol	Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
t1/2 of Carvedilol	Terminal elimination half-life of Carvedilol	Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
CL/F of Carvedilol	Total body clearance of Carvedilol	Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Vd/F of Carvedilol	Apparent volume of distribution of Carvedilol	Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Kyung-Ho Jang, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Congestive Heart Failure; Chronic stable angina
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 188BE18024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No