Healthy VolunteersPhase 1NCT05105698
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg
A Phase 1 study testing gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) and gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) in people with Healthy Volunteers, run by LG Chem.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) and gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting), gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)Drug
Also called 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 called 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105698
- Sponsor's protocol ID
- LG-GLCL003
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05105698
- Acronym / sponsor ID
- LG-GLCL003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)Also: DPP-4 inhibitor and SGLT-2 inhibitor combinationSubjects 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) | Drug | fasting conditions |
| gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)Also: DPP-4 inhibitor and SGLT-2 inhibitor combinationSubjects 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) | Drug | fed conditions |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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-∞)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) and gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) in people with Healthy Volunteers, run by LG Chem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eunjoo cho (+82-2-6987-4284, eunjoo.cho@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.