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

• Sponsor: Celltrion (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05363592
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Days): 20
• Patients Per Site Per Month: 73.1

Study Details

Study Description

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	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: CT-L01 12.5/500 mg; Drug: Alogliptin Benzoate 12.5 mg; Drug: Metformin HCl XR 500 mg	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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
• Anticipated Study Start Date: Jun 25, 2022
• Anticipated Primary Completion Date: Jul 15, 2022
• Anticipated Study Completion Date: Jul 15, 2022

Arms and Interventions

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; FDC tablet, 2 tablets at a time, oral administration
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; Alogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration; Drug: Metformin HCl XR 500 mg; Metformin HCl XR 500 mg 2 tablets, at a time, oral administration

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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

1. AUCinf (Area under the plasma concentration-time curve from time 0 to infinity) [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]

2. AUClast/AUCinf [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]

3. Tmax (Time of 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]

4. t1/2 (Half-life) [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National University Hospital	Daejeon		Korea, Republic of

Sponsors and Collaborators

• Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT05363592
• Other Study ID Numbers: CT-L01-102
• First Posted: May 6, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metformin; Alogliptin

Study Results

No Results Posted as of May 11, 2022