MedDataX Logo

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers

NCT ID: NCT05954247

Last Updated: 2023-07-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers

NCT05954338

Healthy Volunteers
UNKNOWN PHASE1

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions

NCT07260851

Healthy Volunteers
RECRUITING PHASE1

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers

NCT06119945

Healthy Volunteers
UNKNOWN PHASE1

Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

NCT06592495

Healthy Volunteers
NOT_YET_RECRUITING PHASE1

Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.

NCT07267221

Healthy Volunteers
RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention: DWJ1543

Group Type EXPERIMENTAL

DWJ1543

Intervention Type DRUG

DWJ1543

Intervention: DWC202216

Group Type EXPERIMENTAL

DWC202216

Intervention Type DRUG

DWC202216

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DWJ1543

DWJ1543

Intervention Type DRUG

DWC202216

DWC202216

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 19 year old
* Healthy adult volunteers

Exclusion Criteria

* Eye disorders including cataracts
* Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DW_DWJ1543101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
NCT07144176 RECRUITING PHASE1
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers
NCT06109259 UNKNOWN PHASE1
PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers
NCT07256600 COMPLETED PHASE1
Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers
NCT03016520 UNKNOWN PHASE1
Safety and Pharmacokinetics Study of DWC20155 and DWC20156 in Healthy Subjects
NCT02952547 COMPLETED PHASE1
Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects
NCT03016494 UNKNOWN PHASE1
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
NCT04159961 COMPLETED PHASE1
A Crossover Study of DWJ1525 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers
NCT05192395 COMPLETED PHASE1
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers
NCT06010589 UNKNOWN PHASE1
Pharmacokinetics and Safety Following Administration of DWP16001
NCT05414591 COMPLETED PHASE1
Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
NCT05149274 COMPLETED PHASE1
To Evaluate the Safety and PK Characteristics in Healthy Volunteers
NCT06355349 COMPLETED PHASE1
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R
NCT06147908 COMPLETED PHASE1
Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers (II)
NCT04167267 UNKNOWN PHASE1
Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State
NCT05739851 UNKNOWN PHASE1
Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fed State
NCT05739916 UNKNOWN PHASE1
Phamacokinetics and Safety Profiles of DA-5210 10/1000mg in Healthy Subjects at Fed State
NCT05098886 COMPLETED PHASE1
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2
NCT05214690 COMPLETED PHASE1
To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers
NCT05463497 COMPLETED PHASE1
Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers
NCT06318845 COMPLETED PHASE1
This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 and Each Component in Healthy Adult Volunteers in Fed Condition.
NCT05823883 UNKNOWN PHASE1
Clinical Trial of Comparing DA-2902 and DA-2902-R in Healthy Adult Subjects
NCT07239453 ENROLLING_BY_INVITATION PHASE1
Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
NCT01094847 COMPLETED PHASE1
Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fed State
NCT05739877 UNKNOWN PHASE1
Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers
NCT05449704 UNKNOWN PHASE1