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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05376085
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: DA-5215 Tab
  • Drug: DA-5215-R Tab
 Phase 1

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.

  1. Wash out period: at least 7 days

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover Assignment single-dose, 2-sequence, 2-period Bioequivalence StudyCrossover Assignment single-dose, 2-sequence, 2-period Bioequivalence Study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Area Under the plasma Concentration versus time curve(AUCt) [Pre-dose ~ 48hours]

    Area Under the plasma Concentration versus time curve(AUCt)

  2. Peak Plasma Concentration(Cmax) [Pre-dose ~ 48hours]

    Peak Plasma Concentration(Cmax)

Secondary Outcome Measures

  1. Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) [Pre-dose ~ 48hours]

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

  2. Terminal phase of Half-life(t1/2) [Pre-dose ~ 48hours]

    Terminal phase of Half-life(t1/2)

  3. Time of peak concentration(Tmax) [Pre-dose ~ 48hours]

    Time of peak concentration(Tmax)

  4. 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]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. No congenital or chronic diseases or pathological symptoms

  2. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination

  3. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP

  4. 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)

  1. A person who is hypersensitive to any of the IP components

  2. A person who has medical history of mental disease

  3. A person who is judged not to be suitable for the study by the investigator

  4. Lactating or possibly pregnant women

Contacts and Locations

Locations

Site City State Country Postal Code
1 H Plus Yangji Hospital Seoul Korea, Republic of 08779

Sponsors and Collaborators

  • Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: SeungHyun Kang, Ph.D, H Plus Yangji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05376085
Other Study ID Numbers:
  • DTC21-IP064
First Posted:
May 17, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 17, 2022