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

NCT05376085 | Unknown Phase 1

• 1 other identifier: DTC21-IP064
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)

  Pre-dose ~ 48hours

• Terminal phase of Half-life(t1/2)

  Pre-dose ~ 48hours

• 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∞)

  Pre-dose ~ 48hours

Study Arms (2)

RT

EXPERIMENTAL

T: "DA-5215" R: "DA-5215-R"

Drug: DA-5215 Tab; Drug: DA-5215-R Tab

TR

EXPERIMENTAL

T: "DA-5215" R: "DA-5215-R"

Drug: DA-5215 Tab; Drug: DA-5215-R Tab

Interventions

DA-5215 Tab DRUG

single oral administration of 1 tablet of "DA-5215 Tab" with 150mL water

RT; TR

DA-5215-R Tab DRUG

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

RT; TR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

Location

Study Officials

• SeungHyun Kang, Ph.D

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SeungHyun Kang, Ph.D

CONTACT

82-070-4665-9490; juspa@naver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment single-dose, 2-sequence, 2-period Bioequivalence Study

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

KR (1)