Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

NCT ID: NCT04328766

Last Updated: 2021-08-16

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-06

Study Completion Date

2020-11-21

Brief Summary

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An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DWP14012 Cohort A

Group Type EXPERIMENTAL

DWC202005, alone

Intervention Type DRUG

DWC202005, as a single dose

DWP14012 Cohort B

Group Type EXPERIMENTAL

DWP14012 + DWC202005

Intervention Type DRUG

DWP14012 and DWC202005, as a single dose

DWP14012 Cohort C

Group Type EXPERIMENTAL

DWP14012 + DWC202005, after multiple doses of DWP14012

Intervention Type DRUG

DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

Interventions

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DWC202005, alone

DWC202005, as a single dose

Intervention Type DRUG

DWP14012 + DWC202005

DWP14012 and DWC202005, as a single dose

Intervention Type DRUG

DWP14012 + DWC202005, after multiple doses of DWP14012

DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
* Capable of understanding provided information and complying with protocol requirements
* Provide written informed consent to participate in the study
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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Nucleus Network (QPharm)

Queensland, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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DW_DWP14012106

Identifier Type: -

Identifier Source: org_study_id

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