Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Mixed Dyslipidemia

Treatments: Drug: DW5124; Drug: DW5124-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT07319559

DW5124-101

Details and patient eligibility

About

This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.

Enrollment: 55 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Volunteers who are ≥19 years and >65 years old
• Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2

Exclusion criteria

• Clinically significant Medical History
• In the case of women, pregnant(Urine-HCG positive) or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 6 patient groups

Sequence A

Experimental group

Description:

cross-over

Treatment:

Drug: DW5124-R

Drug: DW5124

Sequence B

Experimental group

Description:

cross-over

Treatment:

Drug: DW5124-R

Drug: DW5124

Sequence C

Experimental group

Description:

cross-over

Treatment:

Drug: DW5124-R

Drug: DW5124

Sequence D

Experimental group

Description:

cross-over

Treatment:

Drug: DW5124-R

Drug: DW5124

Sequence E

Experimental group

Description:

cross-over

Treatment:

Drug: DW5124-R

Drug: DW5124

Sequence F

Experimental group

Description:

cross-over

Treatment:

Drug: DW5124-R

Drug: DW5124