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

NCT05105698 | Unknown Phase 1

• 1 other identifier: LG-GLCL003
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin

  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

• Area under the plasma concentrationup up to the last measurable concentration (AUC0-tlast)

  AUC0-tlast will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin

  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

• Area under the plasma concentration-time curve to from time 0 to infinite(AUC0-∞)

  AUC0-∞ will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin

  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

Study Arms (2)

fasting conditions

EXPERIMENTAL

A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)

Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)

fed conditions

EXPERIMENTAL

B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)

Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)

Interventions

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) DRUG

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)

Also known as: DPP-4 inhibitor and SGLT-2 inhibitor combination

fasting conditions

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) DRUG

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)

Also known as: DPP-4 inhibitor and SGLT-2 inhibitor combination

fed conditions

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Interventions

LC15-0444; dapagliflozin; Dipeptidyl-Peptidase IV Inhibitors

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

eunjoo cho

CONTACT

+82-2-6987-4284; eunjoo.cho@lgchem.com

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: October 13, 2021
• First Posted: November 3, 2021
• Study Start: January 1, 2022
• Primary Completion: February 28, 2022
• Study Completion: September 30, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share