Celltrion
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.
Healthy
CT-L01 12.5/500 mg
Alogliptin Benzoate 12.5 mg
Metformin HCl XR 500 mg
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 48 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 25, 2022 |
Estimated Primary Completion Date : | July 5, 2022 |
Estimated Study Completion Date : | July 25, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: CT-L01 12.5/500 mg FDC Tablet Alogliptin Benzoate 12.5 mg/Metformin HCl XR 500 mg, FDC Tablet |
Drug: CT-L01 12.5/500 mg |
Active Comparator: Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg Alogliptin Benzoate 12.5 mg Metformin HCl XR 500 mg |
Drug: Alogliptin Benzoate 12.5 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,