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

Sponsor
LG Chem (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05105698
Collaborator
(none)
28
Enrollment
2
Arms
8.9
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)
  • Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
 Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: fasting conditions

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)
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)
Other Names:
  • DPP-4 inhibitor and SGLT-2 inhibitor combination

    		•
    Experimental: fed conditions

    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)
    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)
    Other Names:
  • DPP-4 inhibitor and SGLT-2 inhibitor combination

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • LG Chem

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LG Chem
    ClinicalTrials.gov Identifier:
    NCT05105698
    Other Study ID Numbers:
    • LG-GLCL003
    First Posted:
    Nov 3, 2021
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dapagliflozin
    Sodium-Glucose Transporter 2 Inhibitors
    Dipeptidyl-Peptidase IV Inhibitors

    Study Results

    No Results Posted as of Nov 3, 2021