A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2

January 28, 2022 updated by: Daewon Pharmaceutical Co., Ltd.

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers

Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Volunteers who are ≥19 years old
  • Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria:

  • Clinically significant Medical History
  • In the case of women, pregnant(Urine-HCG positive) or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
cross-over
Drug: DW1809-1
pelubiprofen 30mg (PELUBI tab.)
Other Names:
  • Reference
Drug: DW1809-T2
pelubiprofen 25mg
Other Names:
  • Test
Experimental: Sequence B
cross-over
Drug: DW1809-1
pelubiprofen 30mg (PELUBI tab.)
Other Names:
  • Reference
Drug: DW1809-T2
pelubiprofen 25mg
Other Names:
  • Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: up to 8 hour
Pharmacokinetics of Pelubiprofen
up to 8 hour
Area under the plasma concentration versus time curve (AUC)
Time Frame: up to 8 hour
Pharmacokinetics of Pelubiprofen
up to 8 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2020

Primary Completion (Actual)

September 8, 2020

Study Completion (Actual)

September 8, 2020

Study Registration Dates

First Submitted

December 12, 2021

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW1809-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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