To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Jul 2024
Shorter than P25 for phase_1 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2024
CompletedStudy Start
First participant enrolled
July 4, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2024
CompletedJuly 10, 2024
July 1, 2024
28 days
July 1, 2024
July 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
0 hour ~ 48 hour after drug administration
Study Arms (2)
Group 1
OTHER* Period 1: CKD-383 two tablets(Fed) * Period 2: CKD-383 two tablets(Fasted)
Group 2
OTHER* Period 1: CKD-383 two tablets(Fasted) * Period 2: CKD-383 two tablets(Fed)
Interventions
After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.
After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.
Eligibility Criteria
You may qualify if:
- Healthy adults aged 19 to 54 years
- BMI measurement result is 18.0 kg/m2 to 30 kg/m2
- Written informed consent
You may not qualify if:
- who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
- administration)
- Other exclusive criteria, as defined in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaeyong chung, PI
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 9, 2024
Study Start
July 4, 2024
Primary Completion
August 1, 2024
Study Completion
August 8, 2024
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share