MedDataX Logo

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

NCT ID: NCT05105698

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

\[Objectives\]

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fasting conditions

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

Group Type EXPERIMENTAL

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

Intervention Type 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)

fed conditions

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

Group Type EXPERIMENTAL

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

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DPP-4 inhibitor and SGLT-2 inhibitor combination DPP-4 inhibitor and SGLT-2 inhibitor combination

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

eunjoo cho

Role: CONTACT

Phone: +82-2-6987-4284

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LG-GLCL003

Identifier Type: -

Identifier Source: org_study_id