A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers

Study Overview
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Brief Summary
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This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.

Official Title
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A Phase I, Randomized, Open-Label, Single-Dose, Crossover Study to Evaluate Food Effect on the Pharmacokinetics and Safety of CT-L01 After Oral Administration in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CT-L01 12.5/1,000 mg
* Drug: CT-L01 12.5/1,000 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-L01 12.5/1,000 mg FDC Tablet, dosing under fasting condition<br>Alogliptin Benzoate 12.5 mg/Metformin HCl XR 1,000 mg, FDC Tablet, dosing under fasting condition | Drug: CT-L01 12.5/1,000 mg<br>* FDC tablet, 2 tablets at a time, oral administration, dosing under fasting condition<br>|
| Experimental: CT-L01 12.5/1,000 mg FDC Tablet, dosing under fed condition<br>Alogliptin Benzoate 12.5 mg/Metformin HCl XR 1,000 mg, FDC Tablet, dosing after high-fat meal | Drug: CT-L01 12.5/1,000 mg<br>* FDC tablet, 2 tablets at a time, oral administration, dosing after high-fat meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast (Area under the plasma concentration-time curve) |  | 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) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf (Area under the plasma concentration-time curve from time 0 to infinity) |  | 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 |  | 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) |  | 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) |  | 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 |