Study to Evaluate the Effect of Food on the Pharmacokinetics and Pharmacodynamics Characteristics in Healthy Adult Volunteers

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: GERD (Gastroesophageal Reflux Disease)

Treatments: Drug: DW4421

Study type: Interventional

Funder types: Industry

Identifiers

NCT07364838

DW4421-101

Details and patient eligibility

About

A Randomized, Open-label, Oral in healthy volunteers

Enrollment: 24 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Volunteers who are ≥19 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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24 participants in 2 patient groups

Sequence A

Experimental group

Description:

Cross-over

Treatment:

Drug: DW4421

Sequence B

Experimental group

Description:

Cross-over

Treatment:

Drug: DW4421