Bioequivalence Study Between DA-5215 Tab and DA-5215-R Tab

Study Overview
=================
Brief Summary
-----------------
An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between DA-5215 Tab and DA-5215-R Tab in Healthy Volunteers

Detailed Description
-----------------
Study design: An open-Label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study Administration method: The subject should maintain a minimum of 10 hours of fasting status before administration, and give an oral dose of 1 tablet (DA-5215 or DA-5215-R) with 150 mL of water at around 8 a.m. on 1D of each period. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the subjects is about one minute apart, considering the blood collection time. Wash out period: at least 7 days Blood collection time: Before the administration,15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 hours after the administration (total 16 times)

Official Title
-----------------
An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence DA-5215 Tab and DA-5215-R Tab in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DA-5215 Tab
* Drug: DA-5215-R Tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A person who aged 19 or older at the time of screening BMI of 18 to 30 (BMI calculation: kg/m2) - Males weighing 50kg or more, Females weighing 45kg or more No congenital or chronic diseases or pathological symptoms A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature Exclusion Criteria: A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP A person who has participated in other clinical trials within six months prior to the first administration of the IP A person who has had whole blood transfusion within 8 weeks or the apheresis within 2 weeks before the first administration of IP A person who has medical history of gastric resection that can affect the drug absorption A person with a history of regular alcohol intake within a month prior to the first administration of the IP: Male: More than 21 cups/week Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits) A person who is hypersensitive to any of the IP components A person who has medical history of mental disease A person who is judged not to be suitable for the study by the investigator Lactating or possibly pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment single-dose, 2-sequence, 2-period Bioequivalence Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT<br>T: DA-5215 R: DA-5215-R | Drug: DA-5215 Tab<br>* single oral administration of 1 tablet of DA-5215 Tab with 150mL water<br>Drug: DA-5215-R Tab<br>* single oral administration of 1 tablet of DA-5215-R Tab with 150mL water<br>|
| Experimental: TR<br>T: DA-5215 R: DA-5215-R | Drug: DA-5215 Tab<br>* single oral administration of 1 tablet of DA-5215 Tab with 150mL water<br>Drug: DA-5215-R Tab<br>* single oral administration of 1 tablet of DA-5215-R Tab with 150mL water<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the plasma Concentration versus time curve(AUCt) | Area Under the plasma Concentration versus time curve(AUCt) | Pre-dose   48hours | 
| Peak Plasma Concentration(Cmax) | Peak Plasma Concentration(Cmax) | Pre-dose   48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) | Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) | Pre-dose   48hours | 
| Terminal phase of Half-life(t1/2) | Terminal phase of Half-life(t1/2) | Pre-dose   48hours | 
| Time of peak concentration(Tmax) | Time of peak concentration(Tmax) | Pre-dose   48hours | 
| Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC∞) | Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC∞) | Pre-dose   48hours |