A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
NCT ID: NCT07128654
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2025-09-17
2025-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm A
CTL02
CTL02
FDC tablet, single dose, oral administration
Arm B
Co-administration of CTL0201 and CTL0202
CTL0201
Nesina, tablet, single dose, oral administration
CTL0202
Jardiance, tablet, single dose, oral administration
Interventions
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CTL02
FDC tablet, single dose, oral administration
CTL0201
Nesina, tablet, single dose, oral administration
CTL0202
Jardiance, tablet, single dose, oral administration
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Days
55 Days
ALL
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Locations
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H+ Yangji Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CT-L02-102
Identifier Type: -
Identifier Source: org_study_id
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