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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2022-11-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention: DWP16001 Drug A

1 tablet, Oral, once daily single dose

Group Type EXPERIMENTAL

DWP16001 Drug A

Intervention Type DRUG

DWP16001 Drug A

Intervention: DWP16001 Drug C

1 tablet, Oral, once daily single dose

Group Type EXPERIMENTAL

DWP16001 Drug C

Intervention Type DRUG

DWP16001 Drug C

Interventions

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DWP16001 Drug A

Intervention Type DRUG

DWP16001 Drug C

Intervention Type DRUG

Eligibility Criteria

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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