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

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Celltrion Healthcare

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: CT-L01 12.5/1,000 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05364164
CT-L01-103

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

CT-L01 12.5/1,000 mg FDC Tablet, dosing under fasting condition
Experimental group
Description:
Alogliptin Benzoate 12.5 mg/Metformin HCl XR 1,000 mg, FDC Tablet, dosing under fasting condition
Treatment:
Drug: CT-L01 12.5/1,000 mg
CT-L01 12.5/1,000 mg FDC Tablet, dosing under fed condition
Experimental group
Description:
Alogliptin Benzoate 12.5 mg/Metformin HCl XR 1,000 mg, FDC Tablet, dosing after high-fat meal
Treatment:
Drug: CT-L01 12.5/1,000 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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