Pharmacokinetics and Safety Following Administration of DWP16001

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWP16001 drug A; Drug: DWP16001 drug B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05414591

DW_DWP16001105

Details and patient eligibility

About

To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers

Enrollment: 38 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers aged ≥ 19 years at screening
• 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
• Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
• Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion criteria

• Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
• Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
• Clinical laboratory test values are outside the accepted normal range at screening
• Other exclusive inclusion 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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38 participants in 2 patient groups

Sequence group A

Experimental group

Description:

DWP16001 A mg 1T

Treatment:

Drug: DWP16001 drug B

Drug: DWP16001 drug A

Sequence group B

Experimental group

Description:

DWP16001 B mg 3T

Treatment:

Drug: DWP16001 drug B

Drug: DWP16001 drug A