Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers

NCT07158346 | Completed Phase 1

• 1 other identifier: CT-L03-101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the pharmacokinetics and safety after co-administration of L03RD1 and L03RD2 or administration of CT-L03 in healthy volunteers.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (2)

• AUCt

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

• Cmax

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

Secondary Outcomes (5)

• AUCinf

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

• AUCt/AUCinf

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

• Tmax

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

• t1/2

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

• CL/F

  Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

Study Arms (2)

A (L03RD1/L03RD2 -> CT-L03)

EXPERIMENTAL

Administration of 1 tablet of L03RD1 and 2 tablets of L03RD2, and taking 14-day wash-out period, and then administration of 1 table of CT-L03

Drug: L03RD1; Drug: L03RD2; Drug: CT-L03

B (CT-L03 -> L03RD1/L03RD2)

EXPERIMENTAL

Administration of 1 table of CT-L03, and taking 14-day wash-out period, and then administration of 1 tablet of L03RD1 and 2 tablets of L03RD2

Drug: L03RD1; Drug: L03RD2; Drug: CT-L03

Interventions

L03RD1 DRUG

1 tablet of L03RD1

A (L03RD1/L03RD2 -> CT-L03); B (CT-L03 -> L03RD1/L03RD2)

L03RD2 DRUG

2 tablets of L03RD2

A (L03RD1/L03RD2 -> CT-L03); B (CT-L03 -> L03RD1/L03RD2)

CT-L03 DRUG

1 tablet of CT-L03

A (L03RD1/L03RD2 -> CT-L03); B (CT-L03 -> L03RD1/L03RD2)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Subject is between 19 and 55 years of age, inclusive, at the time of screening.
• \) Subject has a BMI between 18.0 kg/m² and 29.9 kg/m², inclusive, at the time of screening (≥50 kg for males, ≥45 kg for females).
• \) Subject's seated blood pressure at the time of screening is 90-139mmHg (systolic) and 60-89 mmHg (diastolic), inclusive.
• \) Subject who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination. (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography, etc.)
• \) Subject who the principal investigator(or the delegated investigator) determines that he/she is suitable as a study subject as a result of tests performed during screening, such as diagnostic studies(e.g., hematology test, blood chemistry test, serology test, urinalysis) and electrocardiogram(ECG) set and conducted according to the characteristics of the investigational product.
• \) Subject or his or her spouse or partner agrees to use a medically recognized method of contraception\* (excluding hormonal agents) to rule out the possibility of pregnancy from the date of first administration of the investigational product until 14 days after the last administration of the investigational product. They also agree not to donate sperm or eggs.
• \) Subject who after receiving sufficient explanation and understanding of the purpose, content, characteristics of the investigational product, and expected adverse events, have voluntarily decided to participate and provided written consent.

You may not qualify if:

• \) Subject who have taken a drug that induces or inhibits drug metabolizing enzymes (e.g. barbiturates) within 1 month before the start of the study(date of first administration), or if taken a drug that may affect this study within 10 days before the start of the study(date of first administration).
• \) Participated in another clinical trial or bioequivalence study and received an investigational product within 6 months of first dose of investigational product.
• \) Donated whole blood within 8 weeks, blood components within 2 weeks, or received a transfusion within 4 weeks of first dose of investigational product.
• \) Subject with a history of gastrointestinal resection that may affect drug absorption (excluding appendectomy and hernia surgery).
• \) Subjects who meet any of the following criteria within 1 month prior to the first dose
• a. Excessive alcohol consumption
• b. Smoking more than 20 cigarettes per day
• \) Subjects with any of the following medical conditions
• a. Known hypersensitivity to the active ingredient or any component of the investigational product
• b. Heart failure or a history of heart failure
• c. Active bladder cancer or history of bladder cancer
• d. Hepatic impairment
• e. Severe renal impairment
• f. Uninvestigated macroscopic hematuria
• g. Diabetic ketoacidosis, diabetic coma or pre-coma, Type 1 diabetes, or Type 2 diabetes

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

H plus Yangji Hostpital

Seoul, 08756, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: August 28, 2025
• First Posted: September 5, 2025
• Study Start: August 18, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 23, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

KR (1)