Celltrion
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.
Healthy
CT-L01 12.5/1,000 mg
CT-L01 12.5/1,000 mg
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 24 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 9, 2022 |
Estimated Primary Completion Date : | July 19, 2022 |
Estimated Study Completion Date : | July 25, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: CT-L01 12.5/1,000 mg FDC Tablet, dosing under fasting condition 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 |
Experimental: CT-L01 12.5/1,000 mg FDC Tablet, dosing under fed condition 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 |
Ages Eligible for Study: | 19 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Chungnam National University Hospital
Daejeon, Korea, Republic of,