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Status unknownNCT04003441Updated Jul 1, 2019

Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers

A Phase 1 interventional study of DWP14012 tablet A and DWP14012 tablet B in Healthy, sponsored by Daewoong Pharmaceutical Co. LTD.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-01.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult aged between 19 and 45 at screening
  • Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2
  • Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion criteria

Exclusion Criteria:

  • Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
  • Subjects who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple ppendectomy and herniotomy)
  • Subjects who showed positive result for Helicobacter pylori test
  • Subjects with serum AST (SGOT) or ALT (SGPT) level >1.5 times the upper limit of the normal range at the time of the screening examination
  • Subjects with a history of drug abuse or a positive urine screening for drug abuse
  • Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
  • Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Sequence 1 (Tablet B - Tablet A)

    Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A

    Drug: DWP14012 tablet A · Drug: DWP14012 tablet B

  • Experimental
    Sequence 2 (Tablet A - Tablet B)

    Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B

    Drug: DWP14012 tablet A · Drug: DWP14012 tablet B

Interventions

  • DrugDWP14012 tablet A

    Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A

  • DrugDWP14012 tablet B

    Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B

06

What researchers measure

Primary outcomes

  1. AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

  2. Cmax: Peak concentration of DWP14012

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

Secondary outcomes

  1. AUCinf: Area under the drug concentration-time curve from time 0 to infinity

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

  2. Tmax: Time of maximum concentration

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

  3. t1/2: Terminal elimination half-life

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

  4. CL/F: Apperent Clearance

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

  5. Vd/F: Apparent volume of distribution

    each period

    Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour

07

Study locations

1 of 1 sites recruiting
  • Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 54907, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04003441
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jul 1, 2019
Start date
Jun 2019 (estimated)
Primary completion
Aug 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Jul 1, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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