Healthy Male VolunteersPhase 1NCT03355014

BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone

A Phase 1 study testing Combination of gemigliptin/metformin HCl sustained release 50/1000mg and Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg in people with Healthy Male Volunteers, run by LG Chem at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under… Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Volunteers
What is being tested?: Combination of gemigliptin/metformin HCl sustained release 50/1000mg and Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteSouth Korea
Study dates: 13 Dec 2017to 12 Jan 2018
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 19 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Age between 19 to 45, healthy male subjects(at screening)
Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
FPG 70-125mg/dL glucose level(at screening)
Subjects who are appropriate to conduct study procedure in the decision of investigator
Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Who cannot join

Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, meurology, immunology, pulmonary, endocrine, hematooncology,cardiology,mental disorder.)
Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
Subject who already participated in other trials in 3months
Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Fixed-dose Combinations of Gemigliptin/Metformin HCl Sustained Release 50/1000 mg (25/500 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 1000 mg (500mg x 2 Tablets) Under Fasting and Fed Conditions in Healthy Male Volunteers

Read the detailed description

This study will be conducted in separtes 2 Parts.

Part I is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting condition.

Part II is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fed conditions.

In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects.

the study design and arms are the same in both parts.

Conditions: Healthy Male Volunteers
Being tested: Combination of gemigliptin/metformin HCl sustained release 50/1000mg, Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination of gemigliptin/metformin HCl sustained release 50/1000mgDrug
Gemigliptin/Metformin HCl extended release 25/500mg 2tablets
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mgDrug
Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

Study groups in NCT03355014
Study group	Role	What they receive
Gemigliptin+Metformin combination therapy group	Experimental	Part I (Fasted) Combination therapy of gemigliptin/metformin sustained release 50/1000mg(25/500mg 2tablets), for 1day Part II (High fat diet) Combination therapy of gemigliptin/metformin sustained release 50/1000mg(25/500mg 2tablets), for 1day Receives: Drug: Combination of gemigliptin/metformin HCl sustained release 50/1000mg
Gemigliptin and Metformin coadministration therapy group	Experimental	Part I (Fasted) Coadministration therapy of gemigliptin 50mg and metformin HCL extended relese 1000mg Part II (High fat diet) Coadministration therapy of gemigliptin 50mg and metformin HCL extended relese 1000mg Receives: Drug: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

What is being measured

The primary outcome is the main question the study is designed to answer.

AUClast
To evaluate AUClast of gemigliptin and metformin
Measured: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)
Cmax
To evaluate Cmax of gemigliptin and metformin
Measured: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)

Secondary outcomes (1)

AUEC
This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.
Measured: up to 48hrs of post-dose (pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201712 Jan 2018

First posted28 Nov 2017
Study start13 Dec 2017
Primary completion12 Jan 2018
Study completion12 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy Male 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03355014
Sponsor's protocol ID: LG-DMCL006
Status last verified: Nov 2017
First submitted: 9 Nov 2017
Last updated: 22 Feb 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jin X, Kim E, Huh KY, Hwang I, Cho JY, Yu KS, Lee S. Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects. Transl Clin Pharmacol. 2020 Mar;28(1):43-54. doi: 10.12793/tcp.2020.28.e2. Epub 2020 Mar 30.
PubMed 32274380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Male Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Fixed-dose Combinations of Gemigliptin/Metformin HCl Sustained Release 50/1000 mg (25/500 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 1000 mg (500mg x 2 Tablets) Under Fasting and Fed Conditions in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03355014
Acronym / sponsor ID: LG-DMCL006
Conditions: Healthy Male Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: LG ChemIndustry (pharma, biotech, devices)
Study start: 13 Dec 2017 (actual)
Primary completion: 12 Jan 2018 (actual)
Study completion: 12 Jan 2018 (actual)
First posted: 28 Nov 2017 (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.

Detailed description

This study will be conducted in separtes 2 Parts.

In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects.

the study design and arms are the same in both parts.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gemigliptin+Metformin combination therapy group	Experimental	Drug: Combination of gemigliptin/metformin HCl sustained release 50/1000mgPart I (Fasted) Combination therapy of gemigliptin/metformin sustained release 50/1000mg(25/500mg 2tablets), for 1day Part II (High fat diet) Combination therapy of gemigliptin/metformin sustained release 50/1000mg(25/500mg 2tablets), for 1day
Gemigliptin and Metformin coadministration therapy group	Experimental	Drug: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mgPart I (Fasted) Coadministration therapy of gemigliptin 50mg and metformin HCL extended relese 1000mg Part II (High fat diet) Coadministration therapy of gemigliptin 50mg and metformin HCL extended relese 1000mg

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age between 19 to 45, healthy male subjects(at screening)
Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
FPG 70-125mg/dL glucose level(at screening)
Subjects who are appropriate to conduct study procedure in the decision of investigator
Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Key exclusion criteria (6 listed)

Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, meurology, immunology, pulmonary, endocrine, hematooncology,cardiology,mental disorder.)
Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
Subject who already participated in other trials in 3months
Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.

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
Combination of gemigliptin/metformin HCl sustained release 50/1000mgGemigliptin/Metformin HCl extended release 25/500mg 2tablets	Drug	Gemigliptin+Metformin combination therapy group
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mgZemiglo 50mg 1 tablet Glucophage XR 2 tablets	Drug	Gemigliptin and Metformin coadministration therapy group

Primary outcome

AUClast
Time frame: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)
To evaluate AUClast of gemigliptin and metformin
Cmax
Time frame: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)
To evaluate Cmax of gemigliptin and metformin

1 secondary outcome

AUEC
Time frame: up to 48hrs of post-dose (pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
Derived from this study: PubMed 32274380Jin X, Kim E, Huh KY, Hwang I, Cho JY, Yu KS, Lee S. Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects. Transl Clin Pharmacol. 2020 Mar;28(1):43-54. doi: 10.12793/tcp.2020.28.e2. Epub 2020 Mar 30.
Individual participant dataSharing planned: No

Related trials for Healthy Male Volunteers

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Not yet recruitingPhase 2
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The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast (time frame: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03355014, which also lists 1 linked publication.

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 22 Feb 2018.