Status unknownNCT05699070DWJ1610Updated Apr 4, 2023

Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

A Phase 1 interventional study of DWC202211 100mg and DWC202212 5mg in Drug-drug Interaction, sponsored by Daewoong Pharmaceutical Co. LTD.. Status unknown at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 19 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Drug-drug Interaction

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 24 participants (estimated)

Study arms

Experimental
DWC202211
Drug: DWC202211 100mg
Experimental
DWC202212
Drug: DWC202212 5mg
Experimental
DWC202211 + DWC202212
Drug: DWC202211 100mg + DWC202212 5mg

Interventions

DrugDWC202211 100mg
DWC202211 for 5 days Aspirin 100mg
DrugDWC202212 5mg
DWC202212 for 3 days Rabeprazole 5mg
DrugDWC202211 100mg + DWC202212 5mg
DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg

What researchers measure

Primary outcomes

Cmax
Time frame: up to 27 days
AUClast
Time frame: up to 27 days

Secondary outcomes

DWC202211 Tmax,ss
Time frame: up to 27 days
DWC202211 T1/2,ss
Time frame: up to 27 days
DWC202211 Cmin,ss
Time frame: up to 27 days
DWC202211 Cavg,ss
Time frame: up to 27 days
DWC202211 CLss/F
Time frame: up to 27 days
DWC202211 Vdss/f
Time frame: up to 27 days
DWC202211 PTF
Time frame: up to 27 days
DWC202212 Tmax,ss
Time frame: up to 27 days
DWC202212 T1/2,ss
Time frame: up to 27 days
DWC202212 Cmin,ss
Time frame: up to 27 days
DWC202212 Cavg,ss
Time frame: up to 27 days
DWC202212 CLss/F
Time frame: up to 27 days
DWC202212 Vdss/f
Time frame: up to 27 days
DWC202212 PTF
Time frame: up to 27 days

Study locations

1 site

Seoul National University Hospital
Seoul, South Korea

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Feb 2023 (actual). Primary completion is estimated for Apr 2023, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 10, 2023
First posted: Jan 26, 2023
StartActual: Feb 15, 2023
Primary completionEst.: Apr 24, 2023
CompletionEst.: Jun 1, 2023
Last update: Apr 4, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05699070
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Responsible party: Sponsor
First posted: Jan 26, 2023
Start date: Feb 15, 2023
Primary completion: Apr 24, 2023 (estimated)
Completion: Jun 1, 2023 (estimated)
Last update: Apr 4, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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