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Healthy volunteers test two drug versions for similarity

NCT ID NCT07256600

Knowledge-focused Sponsor: Daewoong Pharmaceutical Co. LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial enrolled 70 healthy adults to compare two tablet formulations of the same drug, DWJ1445 and DWC202506. Participants received a single dose of each in random order, and researchers measured drug levels in the blood to check if the two versions are absorbed similarly. The study was not designed to treat any condition, but to gather information for future drug development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DWJ1445 and DWC202506 (two tablet formulations of the same drug)
What this could lead to
If the two formulations are shown to be bioequivalent, it could support using a new version of the drug in future studies or as a generic alternative.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only checks how the drug is absorbed, not whether it treats any disease. Results may not predict real-world effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

70 people

The number who actually took part.

Started

Nov 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with a body mass index (BMI) between 18 and 30 kg/m² * Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination * Subjects who agree to use a medically acceptable method of contraception Exclusion Criteria: * Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose * Subjects with a history of gastrointestinal surgery that may affect drug absorption * Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects

Contacts and locations

Locations

  • H Plus Yangji Hospital

    Seoul, South Korea

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