HealthyPhase 1NCT05363592
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers
A Phase 1 study testing CT-L01 12.5/500 mg, Alogliptin Benzoate 12.5 mg and Metformin HCl XR 500 mg 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 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CT-L01 12.5/500 mg, Alogliptin Benzoate 12.5 mg and Metformin HCl XR 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2022to 25 Jul 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject aged 19 to 50 years, at screening
- A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0~30.0 kg/m2
- A subject 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 within 28 days before the first administration of the investigational drug
- A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
- A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.
Who cannot join
- A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
- A subject who has an acute illness within 28 days prior to the first dose of investigational drug
- A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
- A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
- A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
- A subject who is judged unsuitable to participate in this study by the principal investigator
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 Bioequivalence After Co-administration of ALO 12.5 mg and MET XR 500 mg or Administration of CT-L01 12.5/500 mg in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- CT-L01 12.5/500 mg, Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-L01 12.5/500 mgDrug
FDC tablet, 2 tablets at a time, oral administration
Alogliptin Benzoate 12.5 mgDrug
Alogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration
Metformin HCl XR 500 mgDrug
Metformin HCl XR 500 mg 2 tablets, at a time, oral administration
| Study group | Role | What they receive |
|---|---|---|
| CT-L01 12.5/500 mg FDC Tablet | Experimental | Alogliptin Benzoate 12.5 mg/Metformin HCl XR 500 mg, FDC Tablet Receives: Drug: CT-L01 12.5/500 mg |
| Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg | Active comparator | 1. Alogliptin Benzoate 12.5 mg
2. Metformin HCl XR 500 mg Receives: Drug: Alogliptin Benzoate 12.5 mg; Drug: Metformin HCl XR 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast (Area under the plasma concentration-time curve)
Measured: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Cmax (Peak Plasma Concentration)
Measured: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Secondary outcomes (4)
AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)
Measured: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
AUClast/AUCinf
Measured: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Tmax (Time of peak plasma concentration)
Measured: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
t1/2 (Half-life)
Measured: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start25 Jun 2022
- Primary completion5 Jul 2022
- Study completion25 Jul 2022
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363592
- Sponsor's protocol ID
- CT-L01-102
- Status last verified
- Jan 2023
- First submitted
- 19 Apr 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. 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 Bioequivalence After Co-administration of ALO 12.5 mg and MET XR 500 mg or Administration of CT-L01 12.5/500 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05363592
- Acronym / sponsor ID
- CT-L01-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 6 May 2022 (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 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-L01 12.5/500 mg FDC Tablet | Experimental | Drug: CT-L01 12.5/500 mgAlogliptin Benzoate 12.5 mg/Metformin HCl XR 500 mg, FDC Tablet |
| Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg | Active comparator | Drug: Alogliptin Benzoate 12.5 mg, Drug: Metformin HCl XR 500 mg1. Alogliptin Benzoate 12.5 mg 2. Metformin HCl XR 500 mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subject aged 19 to 50 years, at screening
- A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0~30.0 kg/m2
- A subject 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 within 28 days before the first administration of the investigational drug
- A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
- A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.
Key exclusion criteria (6 listed)
- A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
- A subject who has an acute illness within 28 days prior to the first dose of investigational drug
- A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
- A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
- A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
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 |
|---|---|---|
| CT-L01 12.5/500 mgFDC tablet, 2 tablets at a time, oral administration | Drug | CT-L01 12.5/500 mg FDC Tablet |
| Alogliptin Benzoate 12.5 mgAlogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration | Drug | Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg |
| Metformin HCl XR 500 mgMetformin HCl XR 500 mg 2 tablets, at a time, oral administration | Drug | Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg |
Primary outcome
AUClast (Area under the plasma concentration-time curve)
Time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Cmax (Peak Plasma Concentration)
Time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
4 secondary outcomes
AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)
Time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
AUClast/AUCinf
Time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Tmax (Time of peak plasma concentration)
Time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
t1/2 (Half-life)
Time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
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 12 Jan 2023.
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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 CT-L01 12.5/500 mg, Alogliptin Benzoate 12.5 mg and Metformin HCl XR 500 mg 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 5 inclusion and 6 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 12 Jan 2023. 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?
AUClast (Area under the plasma concentration-time curve) (time frame: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours). 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 12 Jan 2023.