- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04083846
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
February 3, 2020 updated by: Chong Kun Dang Pharmaceutical
A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D744, Test drug 1: CKD-385 64 mg formulation I, Test drug 2: CKD-385 64 mg formulation II.
Pharmacokinetic blood samples are collected up to 48 hrs.
The pharmacokinetic characteristics and safety are assessed.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jeonju, Korea, Republic of
- Chonbuk National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
- Healthy adult aged over 19 at the time of screening
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
- Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
- 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
- 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
- Subject with the ability and willingness to participate during the study period
Exclusion Criteria
- Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
- 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
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
- Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months prior to screening
- Subject who smokes more than 20 cigarettes a day within 6 months prior to screening
- Subject who took other clinical trial drugs or bioequivalence test drugs within 6 months before the first administration of clinical trial drug
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)
- Subject who has a medical history of significant alcohol abuse or drug abuse within one year prior to screening
- 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).
- 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).
- Subject who donated whole blood within 2 months, or blood components within 1 month prior to first administration of investigational product(s).
- Subject who has hypersensitivity to investigational product(s) or investigational product(s) ingredient.
- Subject is unable to consume a high-fat meal provided during the study.
- Subject who were deemed to be inappropriate to participate in the study by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
|
D744 Cap. 1 Cap., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
Other Names:
|
Experimental: Group 2
|
D744 Cap. 1 Cap., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
Other Names:
|
Experimental: Group 3
|
D744 Cap. 1 Cap., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
Other Names:
|
Experimental: Group 4
|
D744 Cap. 1 Cap., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
Other Names:
|
Experimental: Group 5
|
D744 Cap. 1 Cap., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
Other Names:
|
Experimental: Group 6
|
D744 Cap. 1 Cap., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
Other Names:
CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under Curve last(AUCt)
Time Frame: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
|
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 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
|
Cmax
Time Frame: Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
|
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 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2019
Primary Completion (Actual)
October 21, 2019
Study Completion (Actual)
October 25, 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
Other Study ID Numbers
- A88_04BE1911P
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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