NCT05363384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 11, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

10 days

First QC Date

April 19, 2022

Last Update Submit

January 10, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

CT-L01 25/1,000 mg FDC Tablet

EXPERIMENTAL

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

Drug: CT-L01

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

ACTIVE COMPARATOR

1. Alogliptin Benzoate 25 mg 2. Metformin HCl XR 1,000 mg

Drug: Alogliptin Benzoate 25 mgDrug: Metformin HCl XR 1,000 mg

Interventions

CT-L01DRUG

FDC tablet, single dose, oral administration

CT-L01 25/1,000 mg FDC Tablet
Alogliptin Benzoate 25 mgDRUG

Alogliptin Benzoate 25 mg, oral administration

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

Metformin HCl XR 1,000 mg, oral administration

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

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

May 5, 2022

Study Start

June 11, 2022

Primary Completion

June 21, 2022

Study Completion

July 12, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

KR(1)