A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions
NCT ID: NCT05703984
Last Updated: 2023-01-30
Study Results
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.
UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2023-01-17
2023-04-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
NCT05729386
To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes
NCT01725126
Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
NCT05762471
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
NCT01560481
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
NCT00568984
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GC2129A + Reference drugs
Period 1: GC2129A Period 2: Individual Components
GC2129A(Period 1)
Linagliptin and Metformin Hydrochloride Tablet
Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
Reference drugs + GC2129A
Period 1: Individual Components Period 2: GC2129A
Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
GC2129A(Period 2)
Linagliptin and Metformin Hydrochloride Tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GC2129A(Period 1)
Linagliptin and Metformin Hydrochloride Tablet
Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
GC2129A(Period 2)
Linagliptin and Metformin Hydrochloride Tablet
Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit
* A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination
Exclusion Criteria
* A person who has a history of gastrointestinal surgery
* Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
* A person who participates in another clinical trial or biological equivalence test within six months of the first administration date
* A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
* In the case of female volunteers, a pregnant woman or pregnant woman is suspected
19 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GC Biopharma Corp
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
H Plus YangJi Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GC2129A_BE_FAST_P0101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.