Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg

NCT05105698 — Phase 1, Unknown, 28 participants, LG Chem

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Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers

Registry	NCT05105698
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	28 (Estimated)
Sponsor	LG Chem (Industry)
Conditions	Healthy Volunteers
Interventions	gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting), gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) (Drug)
Dates	start 2022-01-01 (estimated), primary completion 2022-02-28 (estimated), completion 2022-09-30 (estimated), first posted 2021-11-03, last updated 2021-11-03

-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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
fasting conditions	Experimental	Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)	A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)
fed conditions	Experimental	Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)	B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) (Drug), also known as DPP-4 inhibitor and SGLT-2 inhibitor combination: 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)
gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) (Drug), also known as DPP-4 inhibitor and SGLT-2 inhibitor combination: 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)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.