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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: DA-5215 Tab; Drug: DA-5215-R Tab

Detailed Description

1. Study design: An open-Label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study

2. 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.

3. Wash out period: at least 7 days
4. 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)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: SeungHyun Kang, Ph.D; Phone Number: 82-070-4665-9490; Email: juspa@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08779
    • H Plus Yangji Hospital
    • Contact: SeungHyun, Kang; Phone Number: 82-070-4665-9490; Email: juspa@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A person who aged 19 or older at the time of screening

2. BMI of 18 to 30 (BMI calculation: kg/m2)

   - Males weighing 50kg or more, Females weighing 45kg or more

3. No congenital or chronic diseases or pathological symptoms
4. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
5. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
6. 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:

1. 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
2. A person who has participated in other clinical trials within six months prior to the first administration of the IP
3. A person who has had whole blood transfusion within 8 weeks or the apheresis within 2 weeks before the first administration of IP
4. A person who has medical history of gastric resection that can affect the drug absorption

5. 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)
6. A person who is hypersensitive to any of the IP components
7. A person who has medical history of mental disease
8. A person who is judged not to be suitable for the study by the investigator
9. Lactating or possibly pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT; T: "DA-5215" R: "DA-5215-R"	Drug: DA-5215 Tab; single oral administration of 1 tablet of "DA-5215 Tab" with 150mL water; Drug: DA-5215-R Tab; single oral administration of 1 tablet of "DA-5215-R Tab" with 150mL water
Experimental: TR; T: "DA-5215" R: "DA-5215-R"	Drug: DA-5215 Tab; single oral administration of 1 tablet of "DA-5215 Tab" with 150mL water; Drug: DA-5215-R Tab; single oral administration of 1 tablet of "DA-5215-R Tab" with 150mL water

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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: SeungHyun Kang, Ph.D, H Plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DTC21-IP064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No