HealthyPhase 1NCT07128654
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
A Phase 1 study testing CTL02, CTL0201 and CTL0202 in people with Healthy, run by Celltrion at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CTL02, CTL0201 and CTL0202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Sep 2025to 26 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Healthy
- Being tested
- CTL02, CTL0201, CTL0202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTL02Drug
FDC tablet, single dose, oral administration
CTL0201Drug
Nesina, tablet, single dose, oral administration
CTL0202Drug
Jardiance, tablet, single dose, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | CTL02 Receives: Drug: CTL02 |
| Arm B | Active comparator | Co-administration of CTL0201 and CTL0202 Receives: Drug: CTL0201; Drug: CTL0202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt (Area under the plasma concentration-time curve)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start17 Sep 2025
- Primary completion5 Oct 2025
- Study completion26 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128654
- Sponsor's protocol ID
- CT-L02-102
- Status last verified
- Nov 2025
- First submitted
- 14 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07128654
- Acronym / sponsor ID
- CT-L02-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 26 Oct 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CTL02CTL02 |
| Arm B | Active comparator | Drug: CTL0201, Drug: CTL0202Co-administration of CTL0201 and CTL0202 |
Who may qualify
- Ages
- 19 to 55 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTL02FDC tablet, single dose, oral administration | Drug | Arm A |
| CTL0201Nesina, tablet, single dose, oral administration | Drug | Arm B |
| CTL0202Jardiance, tablet, single dose, oral administration | Drug | Arm B |
Primary outcome
AUCt (Area under the plasma concentration-time curve)
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTL02, CTL0201 and CTL0202 in people with Healthy, run by Celltrion at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt (Area under the plasma concentration-time curve) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.