Type 2 Diabetes Mellitus
Conditions
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
Detailed description
Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
Interventions
DRUGCKD-383(Fed)
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.
DRUGCKD-383(Fasted)
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.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults aged 19 to 54 years * BMI measurement result is 18.0 kg/m2 to 30 kg/m2 * Written informed consent * Other inclusion criteria, as defined in the protocol
Exclusion criteria
* 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 1 administration) * Other exclusive criteria, as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2) | 0 hour ~ 48 hour after drug administration | Pharmacokinetic characterization |
| Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2) | 0 hour ~ 48 hour after drug administration | Pharmacokinetic characterization |
Contacts
Primary ContactJisoo Kim, PL
Outcome results
None listed