A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
NCT ID: NCT05729386
Last Updated: 2023-02-15
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
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UNKNOWN
PHASE1
34 participants
INTERVENTIONAL
2023-02-06
2023-04-17
Brief Summary
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Detailed Description
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For healthy subjects, each 17 subjects are assigned to each of the two groups(total 34 subjects). If the subject administrate GC2129A in the first period, the subject will be administrated reference drugs in the second period after washout(over 7 days). Conversely, if the subject administrate reference drugs in the first period, the subject will be administrated with GC2129A in the second period.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
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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
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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
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GC Biopharma Corp
INDUSTRY
Responsible Party
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Locations
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H Plus YangJi Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GC2129A_BE_FED_P0102
Identifier Type: -
Identifier Source: org_study_id
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