Healthy Volunteers
Conditions
Brief summary
A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers
Detailed description
\[Objectives\] * Primary: To investigate the food-effect bioavailability of absorption of gemigliptin and dapagliflozin 50/10 mg fixed dose combination film-coated tablet in healthy subjects under fed and fasting conditions * Secondary: To evaluate safety of investigational product under fed and fasting conditions
Interventions
DRUGgemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)
Subjects will check-in a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.(fasting)
DRUGgemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
Subjects will check-in a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.(fed)
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/m2. All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.
Exclusion criteria
* History serious hypersensitivity reactions * History or evidence of clinically significant renal, hepatic, gastrointestinal * Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 * History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period * History or evidence of family diabetes * History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma * etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00 | Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin |
| Area under the plasma concentrationup up to the last measurable concentration (AUC0-tlast) | Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00 | AUC0-tlast will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin |
| Area under the plasma concentration-time curve to from time 0 to infinite(AUC0-∞) | Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00 | AUC0-∞ will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin |
Contacts
Primary Contacteunjoo cho
Outcome results
None listed