Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

NCT ID: NCT05699070

Last Updated: 2023-04-04

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-06-01

Brief Summary

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An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy

Detailed Description

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Conditions

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Drug-drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DWC202211

Group Type EXPERIMENTAL

DWC202211 100mg

Intervention Type DRUG

DWC202211 for 5 days

Aspirin 100mg

DWC202212

Group Type EXPERIMENTAL

DWC202212 5mg

Intervention Type DRUG

DWC202212 for 3 days

Rabeprazole 5mg

DWC202211 + DWC202212

Group Type EXPERIMENTAL

DWC202211 100mg + DWC202212 5mg

Intervention Type DRUG

DWC202211 + DWC202212 for 5 days

Aspirin 100mg, Rabeprazole 5mg

Interventions

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DWC202211 100mg

DWC202211 for 5 days

Aspirin 100mg

Intervention Type DRUG

DWC202212 5mg

DWC202212 for 3 days

Rabeprazole 5mg

Intervention Type DRUG

DWC202211 100mg + DWC202212 5mg

DWC202211 + DWC202212 for 5 days

Aspirin 100mg, Rabeprazole 5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1610101

Identifier Type: -

Identifier Source: org_study_id

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