Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWP16001 Drug C; Drug: DWP16001 Drug A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05465668

DW_DWP16001106

Details and patient eligibility

About

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

Full description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.

Enrollment: 43 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2

☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2

Exclusion criteria

• musculoskeletal diseases
• mental diseases
• hemato-oncologic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Intervention: DWP16001 Drug A

Experimental group

Description:

1 tablet, Oral, once daily single dose

Treatment:

Drug: DWP16001 Drug A

Intervention: DWP16001 Drug C

Experimental group

Description:

1 tablet, Oral, once daily single dose

Treatment:

Drug: DWP16001 Drug C