NCT05568121

Brief Summary

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

October 3, 2022

Last Update Submit

January 10, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

  • Cmax

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

Secondary Outcomes (5)

  • AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

  • Tmax (Time of peak plasma concentration)

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

  • AUCt/AUCinf

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

  • t1/2 (Half-life)

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

  • CL/F

    Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

Study Arms (2)

A (L04RD1 -> L04TD1)

EXPERIMENTAL

Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1

Drug: L04RD1Drug: L04TD1

B (L04TD1 -> L04RD1)

EXPERIMENTAL

Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1

Drug: L04TD1Drug: L04RD1

Interventions

L04RD1DRUG

1 tablet of L04RD1

A (L04RD1 -> L04TD1)
L04TD1DRUG

1 tablet of L04TD1

A (L04RD1 -> L04TD1)

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0\~29.9 kg/m2
  • A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 30 days before the first administration of the investigational drug
  • A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
  • A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.

You may not qualify if:

  • A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
  • A subject who has an acute illness within 30 days prior to the first dose of investigational drug
  • A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
  • A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
  • A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
  • A subject who is judged unsuitable to participate in this study by the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H plus Yangji Hospital

Seoul, 08756, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 5, 2022

Study Start

September 1, 2022

Primary Completion

October 9, 2022

Study Completion

October 27, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

KR(1)