To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers

NCT ID: NCT06492655

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-04
• Study Completion Date: 2024-08-08

Brief Summary

This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Detailed Description

Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

Group 1

• Period 1: CKD-383 two tablets(Fed)
• Period 2: CKD-383 two tablets(Fasted)

Group Type: OTHER

CKD-383(Fed)

Intervention Type: DRUG

After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.

CKD-383(Fasted)

Intervention Type: DRUG

After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.

Group 2

• Period 1: CKD-383 two tablets(Fasted)
• Period 2: CKD-383 two tablets(Fed)

Group Type: OTHER

CKD-383(Fed)

Intervention Type: DRUG

After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.

CKD-383(Fasted)

Intervention Type: DRUG

After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.

Interventions

CKD-383(Fed)

After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.

Intervention Type: DRUG

CKD-383(Fasted)

After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.

Intervention Type: DRUG

Other Intervention Names

Lobeglitazone, Empagliflozin, Metformin; Lobeglitazone, Empagliflozin, Metformin

Eligibility Criteria

Inclusion Criteria

• Healthy adults aged 19 to 54 years
• BMI measurement result is 18.0 kg/m2 to 30 kg/m2
• Written informed consent

Exclusion Criteria

• who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period

1 administration)

• Other exclusive criteria, as defined in the protocol

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaeyong chung, PI

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Central Contacts

Jisoo Kim, PL

Role: CONTACT

jisoo.kim@ckdpharm.com

02-6373-0785

Other Identifiers

A101_06FDI2404

Identifier Type: -

Identifier Source: org_study_id