To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2023-11-30

Brief Summary

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This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DWP16001 to Group A

Group A: Fasting in Period 1 / Fed in Period 2

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

DWP16001 0.3mg

DWP16001 to Group B

Group B: Fed in Period 1 / Fasting in Period 2

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

DWP16001 0.3mg

Interventions

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DWP16001

DWP16001 0.3mg

Intervention Type DRUG

Other Intervention Names

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DWP16001 0.3mg

Eligibility Criteria

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Inclusion Criteria

1. A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
2. A person who is 19 years of age or more at the time of screening.
3. Those with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.

Exclusion Criteria

1. A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
2. A person who has a history of gastrointestinal surgery/disease, such as Crohn's disease, ulcer, acute or chronic pancreatitis, which may affect the absorption of drug for clinical trials. (Except for simple appendectomy or hernia surgery)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes