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NCT05363592 | Completed | Healthy


A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers
Sponsor:

Celltrion

Brief 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.

Condition or disease

Healthy

Intervention/treatment

CT-L01 12.5/500 mg

Alogliptin Benzoate 12.5 mg

Metformin HCl XR 500 mg

Phase

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
Criteria
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

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

Location Details


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A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Korea, Republic of,

Chungnam National University Hospital

Daejeon, Korea, Republic of,

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