NCT04939779

Brief Summary

The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch# 1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2021

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

January 14, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

10 days

First QC Date

February 21, 2021

Last Update Submit

June 17, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic evaluation: The observed maximum concentration(Cmax)

    Pharmacokinetic parameters will be assessed using non-compartmental method

    0-12hours

  • Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast)

    Area under the plasma concentration curve from zero until the last measurable concentration

    0-12hours

Secondary Outcomes (5)

  • Pharmacokinetic evaluation: Time to reach Cmax(Tmax)

    0-12hours

  • Pharmacokinetic evaluation: Elimination half-life(t1/2)

    0-12hours

  • Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F)

    0-12hours

  • Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F)

    0-12hours

  • Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf)

    0-12hours

Study Arms (2)

Group A

EXPERIMENTAL

Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)

Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Group B

EXPERIMENTAL

Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Drug: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)Drug: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)

Interventions

LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)DRUG

Oral administration

Group AGroup B
LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)DRUG

Oral administration

Group AGroup B

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A person who is a healthy adult aged between 19 and 45 years old with the result of BMI between 18.0 kg/m2 and 28.0 kg/m2
  • A healthy adult whose weight is over 50 kg
  • A person who is deemed suitable for a clinical trial subject in physical examination, vital sign tests, diagnostic examination, and 12-lead ECG by the medical doctor, etc.

You may not qualify if:

  • A person who has a clinically significant history of the disease, such as liver, kidney, gastrointestinal disease, respiratory tract disease, muscular-skeletal disease, endocrine disease, nervous system disease, blood ∙ tumor disease, cardiovascular disease, etc.
  • A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (1)

  • Koh J, Khwarg J, Cho YL, Yu KS, Chung JY. Comparative pharmacokinetics study of two tablet formulations of delpazolid, a novel oxazolidinone class antibiotic. Transl Clin Pharmacol. 2024 Dec;32(4):216-224. doi: 10.12793/tcp.2024.32.e18. Epub 2024 Dec 18.

    PMID: 39801777DERIVED

MeSH Terms

Interventions

delpazolidDrug Evaluation

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Jae-Yong Chung

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

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

February 21, 2021

First Posted

June 25, 2021

Study Start

January 14, 2021

Primary Completion

January 24, 2021

Study Completion

February 1, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)