---
title: Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
nct_id: NCT04490434
overall_status: UNKNOWN
phase: PHASE1
sponsor: Daewoong Pharmaceutical Co. LTD.
study_type: INTERVENTIONAL
primary_condition: Healthy Male Volunteers
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04490434.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04490434"
ct_last_update_post_date: 2020-07-29
last_seen_at: "2026-05-12T07:23:04.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs

**Official Title:** A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers

**NCT ID:** [NCT04490434](https://clinicaltrials.gov/study/NCT04490434)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** Daewoong Pharmaceutical Co. LTD.
- **Conditions:** Healthy Male Volunteers
- **Start Date:** 2020-06-19
- **Completion Date:** 2020-11-30
- **CT.gov Last Update:** 2020-07-29

## Brief Summary

drug-drug interaction between DWP14012 and three different kinds of NSAIDs

## Detailed Description

to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those 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 appendectomy and herniotomy)
* Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* 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
```

## Arms

- **Cohort 1, A (DWP14012/Celecoxib)** (EXPERIMENTAL) — Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
- **Cohort 1, B (DWP14012/Celecoxib)** (EXPERIMENTAL) — Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
- **Cohort 2, C (DWP14012/Naproxen)** (EXPERIMENTAL) — Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
- **Cohort 2, D (DWP14012/Naproxen)** (EXPERIMENTAL) — Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
- **Cohort 3, E (DWP14012/Meloxicam)** (EXPERIMENTAL) — Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
- **Cohort 3, F (DWP14012/Meloxicam)** (EXPERIMENTAL) — Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.

## Interventions

- **DWP14012** (DRUG) — DWP14012 40mg, bid
- **Celecoxib** (DRUG) — Celecoxib 200mg, bid
- **Naproxen** (DRUG) — Naproxen 500mg, bid
- **Meloxicam** (DRUG) — Meloxicam 15mg, qd

## Primary Outcomes

- **Arm A, Cmax,ss of Celecoxib** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Maximum measured plasma concentration at steady-state
- **Arm A, AUCτ,ss of Celecoxib** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Area under the plasma concentration-time curve
- **Arm B, Cmax,ss of DWP14012** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Maximum measured plasma concentration at steady-state
- **Arm B, AUCτ,ss of DWP14012** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Area under the plasma concentration-time curve
- **Arm C, Cmax,ss of Naproxen** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Maximum measured plasma concentration at steady-state
- **Arm C, AUCτ,ss of Naproxen** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Area under the plasma concentration-time curve
- **Arm D, Cmax,ss of DWP14012** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Maximum measured plasma concentration at steady-state
- **Arm D, AUCτ,ss of DWP14012** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours))_ — Area under the plasma concentration-time curve
- **Arm E, Cmax,ss of Meloxicam** _(time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours))_ — Maximum measured plasma concentration at steady-state
- **Arm E, AUCτ,ss of Meloxicam** _(time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours))_ — Area under the plasma concentration-time curve
- **Arm D, Cmax,ss of DWP14012** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours))_ — Maximum measured plasma concentration at steady-state
- **Arm D, AUCτ,ss of DWP14012** _(time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours))_ — Area under the plasma concentration-time curve

## Locations (1)

- Seoul National University Hospital, Seoul, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04490434.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04490434*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*