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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CT-L01; Drug: Alogliptin Benzoate 25 mg; Drug: Metformin HCl XR 1,000 mg

• Registration Number: NCT05363384
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-05
• Study Start: 2022-06-11
• Primary Completion: 2022-06-21
• Study Completion: 2022-07-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CT-L01 25/1,000 mg FDC Tablet	CT-L01	Alogliptin Benzoate 25 mg/Metformin HCl XR 1,000 mg, FDC Tablet
Alogliptin Benzoate 25 mg, Metformin HCl XR 1,000 mg	Alogliptin Benzoate 25 mg	1. Alogliptin Benzoate 25 mg 2. Metformin HCl XR 1,000 mg
Alogliptin Benzoate 25 mg, Metformin HCl XR 1,000 mg	Metformin HCl XR 1,000 mg	1. Alogliptin Benzoate 25 mg 2. Metformin HCl XR 1,000 mg

Primary Outcome Measures

Name	Time	Method
AUClast (Area under the plasma concentration-time curve)	Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Cmax (Peak Plasma Concentration)	Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours

Secondary Outcome Measures

Name	Time	Method
AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)	Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
AUClast/AUCinf	Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Tmax (Time of peak plasma concentration)	Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
t1/2 (Half-life)	Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of