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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05376085
• Other study ID #: DTC21-IP064
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2022
• Est. completion date: July 2022

Study information

• Verified date: May 2022
• Source: Dong-A ST Co., Ltd.
• Contact: SeungHyun Kang, Ph.D
• Phone: 82-070-4665-9490
• Email: juspa[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DA-5215 Tab
single oral administration of 1 tablet of "DA-5215 Tab" with 150mL water
• DA-5215-R Tab
single oral administration of 1 tablet of "DA-5215-R Tab" with 150mL water

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the plasma Concentration versus time curve(AUCt)	Area Under the plasma Concentration versus time curve(AUCt)	Pre-dose ~ 48hours
Primary	Peak Plasma Concentration(Cmax)	Peak Plasma Concentration(Cmax)	Pre-dose ~ 48hours
Secondary	Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8)	Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8)	Pre-dose ~ 48hours
Secondary	Terminal phase of Half-life(t1/2)	Terminal phase of Half-life(t1/2)	Pre-dose ~ 48hours
Secondary	Time of peak concentration(Tmax)	Time of peak concentration(Tmax)	Pre-dose ~ 48hours
Secondary	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC8)	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC8)	Pre-dose ~ 48hours