A Bioequivalence Study of CT-L02 Compared to Co-administr... | NCT07128654

Studies
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers

NCT07128654

Sponsor

Celltrion

Status

Completed

Last Update Posted

Nov 17, 2025Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CTL02
CTL0201
CTL0202

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2025Actual

Primary Completion Date

Oct 5, 2025Actual

Completion Date

Oct 26, 2025Actual

First Submitted Date

Aug 14, 2025

First Submission Date that Met QC Criteria

Aug 14, 2025

First Posted Date

Aug 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	CTL02	Drug: CTL02
Arm B	Active Comparator	Co-administration of CTL0201 and CTL0202	Drug: CTL0201 Drug: CTL0202

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTL02	Drug	FDC tablet, single dose, oral administration	Arm A
CTL0201

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt (Area under the plasma concentration-time curve)		0(Pre-dose), 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 48, 72hrs
Cmax (Peak Plasma Concentration)		0(Pre-dose), 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 48, 72hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy participant aged 19 to 55 years, at screening
A participant who has a body mass index (BMI) of 18.0~29.9 kg/m2, at screening
A participant 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

Exclusion Criteria:

A participant who has taken drugs that induce or inhibit drug metabolizing enzymes
A participant who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
A participant who has a history of gastrointestinal surgery that may affect drug absorption

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Days

Maximum Age

55 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided