- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322032
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389 in Healthy Volunteers Under Fasting Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Min-gul Kim
- Phone Number: +82-63-259-3480
- Email: mgkim@jbcp.kr
Study Contact Backup
- Name: Kyung-Ho Jang
- Email: khjang@jbcp.kr
Study Locations
-
-
-
Jeonju, Korea, Republic of
- Chonbuk National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults over the age of 19 years and under the age of 65 years at the time of screening
Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight of males ≥ 55 kg and females ≥ 45 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 consents to the use of reliable contraception during the clinical trial and not to donate his sperm during the study period and until 1 month after the last administration of investigational product
- Subject with the ability and willingness to participate during the study period
Exclusion Criteria:
- Subjects with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease
- Subjects with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
Subjects with the following laboratory test result:
☞ ALT or AST > 2x the upper limit of the normal range
- History of regular alcohol consumption exceeding 210 g/week within 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
- Subjects who smoked more than 20 cigarettes per day within 6 months prior to screening
- Subjects who had been administered investigational product(s) from other clinical study or bioequivalence study within 6 months prior to the first dose of this study
Following vital signs at screening
☞ Sitting systolic blood pressure ≥160 mmHg or <90 mmHg and/or a sitting diastolic blood pressure ≥100 mmHg or <50 mmHg at screening
- Subjects with a medical history of significant alcohol or drug abuse within one year prior to the screening
- Subjects 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 dose of investigational product(s)
- Subjects who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product(s)
- Subjects who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product(s)
- Subjects with a severe acute/chronic physical and mental conditions that can increase risk or interfere with the interpretation of the results of test
- Subjects who had Type 1 diabetes or diabetic ketoacidosis
- Subjects with known hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions or angioedema
- Subject had renal impairment(eGFR < 60 mL/min/1.73 m²)
- Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subject who is a pregnant or nursing woman
- Subject had heart failure(NYHA class IV)
- Subjects who were deemed 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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
|
D759 Tab. 1 Tab.
and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.
Other Names:
CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.
Other Names:
|
Experimental: Group 2
|
D759 Tab. 1 Tab.
and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.
Other Names:
CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCt(Area Under Curve last)
Time Frame: Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
|
Area under the plasma concentration time curve of CKD-389/D759&D308, from time zero up to the last measurable concentration.
|
Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
|
Cmax
Time Frame: Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
|
The maximum concentration observed of CKD-389/D759&D308 over blood sampling time.
|
Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A102_02BE2003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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