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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CTL0202; Drug: CTL02; Drug: CTL0201

Study type: Interventional

Funder types: Industry

Identifiers

NCT07128654

CT-L02-102

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 55 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm A

Experimental group

Description:

CTL02

Treatment:

Drug: CTL02

Arm B

Active Comparator group

Description:

Co-administration of CTL0201 and CTL0202

Treatment:

Drug: CTL0201

Drug: CTL0202