Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06483243

A101_05BE2315

Details and patient eligibility

About

This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Full description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)

Enrollment: 45 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults aged 19 to 65 years
• Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
• within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
• 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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45 participants in 2 patient groups

Group A

Experimental group

Description:

* Phase 1: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference) * Phase 2: CKD-383 2 tablets(Test)

Treatment:

Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Group B

Experimental group

Description:

* Phase 1: CKD-383 2 tablets(Test) * Phase 2: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)

Treatment:

Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG