A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers

NCT ID: NCT05363384

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-11
• Study Completion Date: 2022-07-12

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT-L01 25/1,000 mg FDC Tablet

Alogliptin Benzoate 25 mg/Metformin HCl XR 1,000 mg, FDC Tablet

Group Type: EXPERIMENTAL

CT-L01

Intervention Type: DRUG

FDC tablet, single dose, oral administration

Alogliptin Benzoate 25 mg, Metformin HCl XR 1,000 mg

1. Alogliptin Benzoate 25 mg

2. Metformin HCl XR 1,000 mg

Group Type: ACTIVE_COMPARATOR

Alogliptin Benzoate 25 mg

Intervention Type: DRUG

Alogliptin Benzoate 25 mg, oral administration

Metformin HCl XR 1,000 mg

Intervention Type: DRUG

Metformin HCl XR 1,000 mg, oral administration

Interventions

CT-L01

FDC tablet, single dose, oral administration

Intervention Type: DRUG

Alogliptin Benzoate 25 mg

Alogliptin Benzoate 25 mg, oral administration

Intervention Type: DRUG

Metformin HCl XR 1,000 mg

Metformin HCl XR 1,000 mg, oral administration

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

CT-L01-101

Identifier Type: -

Identifier Source: org_study_id