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

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CKD-383(Fed); Drug: CKD-383(Fasted)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06492655

A101_06FDI2404

Details and patient eligibility

About

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

Full 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)

Enrollment: 28 estimated patients

Sex: All

Ages: 19 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults aged 19 to 54 years
• BMI measurement result is 18.0 kg/m2 to 30 kg/m2
• Written informed consent
• Other inclusion criteria, as defined in the protocol

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Group 1

Other group

Description:

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

Treatment:

Drug: CKD-383(Fasted)

Drug: CKD-383(Fed)

Group 2

Other group

Description:

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

Treatment:

Drug: CKD-383(Fasted)

Drug: CKD-383(Fed)