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Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04328766
Enrollment
36
Registered
2020-03-31
Start date
2020-09-06
Completion date
2020-11-21
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-drug Interaction

Brief summary

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

Interventions

DRUGDWC202005, alone

DWC202005, as a single dose

DRUGDWP14012 + DWC202005

DWP14012 and DWC202005, as a single dose

DRUGDWP14012 + DWC202005, after multiple doses of DWP14012

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

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Treatment-Emergent Adverse Eventsup to 19 days
Area under the plasma drug concentration-time curveupto 48 hours postdoseAUClast of DWC202005
Peak Plasma Concentration (Cmax)upto 48 hours postdoseCmax of DWC202005

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026