Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers

Phase 1

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Reference drug; Drug: Test drug

• Registration Number: NCT04075643
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers.

Detailed Description

To healthy subjects of fifty-two (52), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D935 Test drug: CKD-385 Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Status Verified: 2019-09
• Study First Posted: 2019-09-03
• Study Start: 2019-09-19
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 with the ability and willingness to participate during the study period

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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 does not consent to reliable contraception during the entire period of clinical trial and until 7 days after the last administration of investigational product.

14. Subject who were deemed to be inappropriate to participate in the study by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Reference drug	1. Period 1: Reference drug 2. Period 2: Test drug
Group 1	Test drug	1. Period 1: Reference drug 2. Period 2: Test drug
Group 2	Reference drug	1. Period 1: Test drug 2. Period 2: Reference drug
Group 2	Test drug	1. Period 1: Test drug 2. Period 2: Reference drug

Primary Outcome Measures

Name	Time	Method
AUCt(Area Under Curve last)	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours	Area under the plasma concentration time curve of CKD-385/D935, from time zero up to the last measurable concentration.
Cmax	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours	The maximum concentration observed of CKD-385/D935 over blood sampling time.

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of