Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fasting Conditions

This study is a randomized, open-label, fasting, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Reference drug; Drug: Test drug

Detailed Description

To 16 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: D744 Test drug: CKD-385 64 mg formulation I Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk 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: All

Description

Inclusion Criteria

1. Healthy adult aged over 19 at the time of screening

2. Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight ≥ 55 kg

   # BMI=Weight(kg) / Height(m)²

3. Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
4. Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
5. Subject who signed an informed consent form approved by the Institutional Review Board(IRB) of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
6. Subject who must consent to the use of reliable contraception and not to donate sperm, from the 1st administration of the investigational product until 1 month after the last administration of investigational product
7. Subject with the ability and willingness to participate during the study period

Exclusion Criteria

1. Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
2. Subject with a medical 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

   *Alanine Transaminase(ALT) or Aspartate Transaminase(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 prior to screening
5. Subject who smokes more than 20 cigarettes a day within 6 months prior to screening
6. Subject who took other clinical trial drugs or bioequivalence test drugs within 6 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, not less than 140 mmHg or diastolic blood pressure less than 60 mmHg or not less than 90 mmHg in a sitting position
   • Severe bradycardia (less than 50 beats/minute)
8. Subject who has a medical history of significant alcohol abuse or drug abuse within one year prior to screening
9. Subject who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first administration of investigational product(s).
10. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of investigational product(s).
11. Subject who donated whole blood within 2 months, or blood components within 1 month prior to first administration of investigational product(s).
12. Subject who has hypersensitivity to investigational product(s) or investigational product(s) ingredient.
13. Subject who were deemed to be inappropriate to participate in the study by the investigator.

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
Experimental: Group 1; Period 1: Reference drug; Period 2: Test drug	Drug: Reference drug; D744 Cap. 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug; CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I
Experimental: Group 2; Period 1: Test drug; Period 2: Reference drug	Drug: Reference drug; D744 Cap. 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug; CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under Curve last(AUCt)	Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Cmax	The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: September 8, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: A88_05BE1912P

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