A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.

Detailed Description
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This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered. 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.

Official Title
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Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: GC2129A(Period 1)
* Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)
* Drug: GC2129A(Period 2)
* Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person who is 19 years of age or older at the time of a screening visit 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: Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology. 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 A person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria In the case of female volunteers, a pregnant woman or pregnant woman is suspected

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC2129A + Reference drugs<br>Period 1: GC2129A Period 2: Individual Components | Drug: GC2129A(Period 1)<br>* Linagliptin and Metformin Hydrochloride Tablet<br>Drug: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)<br>* Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)<br>|
| Experimental: Reference drugs + GC2129A<br>Period 1: Individual Components Period 2: GC2129A | Drug: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)<br>* Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)<br>Drug: GC2129A(Period 2)<br>* Linagliptin and Metformin Hydrochloride Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) parameters - Cmax | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours | 
| Pharmacokinetic (PK) parameters - AUCt | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) parameters - AUCinf | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours | 
| Pharmacokinetic (PK) parameters - Tmax | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours | 
| Pharmacokinetic (PK) parameters - t1/2 | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GC2129A, PK