---
title: Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
nct_id: NCT05304845
overall_status: COMPLETED
phase: PHASE1
sponsor: Daewoong Pharmaceutical Co. LTD.
study_type: INTERVENTIONAL
primary_condition: Drug Drug Interaction
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05304845.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05304845"
ct_last_update_post_date: 2023-04-05
last_seen_at: "2026-05-12T06:26:02.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

**Official Title:** A Randomized, Open-label Study to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

**NCT ID:** [NCT05304845](https://clinicaltrials.gov/study/NCT05304845)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Daewoong Pharmaceutical Co. LTD.
- **Conditions:** Drug Drug Interaction
- **Start Date:** 2022-03-21
- **Completion Date:** 2022-05-22
- **CT.gov Last Update:** 2023-04-05

## Brief Summary

This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.

## Eligibility

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

```
Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

  ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
* For women, negative urine pregnancy test (hCG) at the screening visit

Exclusion Criteria:

* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, salicylic acid, or other drugs (non-steroidal anti-inflammatory drug \[NSAIDs\], antibiotics, etc.)
* Women who are or may be pregnant, or are breast-feeding
* Subjects with a history related to blood clotting disorder or bleeding
* Subjects with a medical diagnosis of functional constipation
* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration, and disagreed to refrain from donating sperms during this period
* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
```

## Arms

- **Cohort 1** (EXPERIMENTAL) — Aspirin (substrate), DWP14012 (Perpetrator)
- **Cohort 2** (EXPERIMENTAL) — DWP14012 (substrate), Aspirin (Perpetrator)

## Interventions

- **DWP14012** (DRUG) — Potassium-competitive acid blocker
- **Aspirin** (DRUG) — acetylsalicylic acid

## Primary Outcomes

- **Cmax of aspirin** _(time frame: Up to 21 days)_
- **Cmax,ss of DWP14012** _(time frame: Up to 13 days)_
- **Emax** _(time frame: Up to 21 days)_
- **AUClast of aspirin** _(time frame: Up to 21 days)_
- **AUCτ,ss of DWP14012** _(time frame: Up to 13 days)_
- **time to Emax** _(time frame: Up to 21 days)_
- **AUEC** _(time frame: Up to 21 days)_

## Locations (1)

- Seoul National University Hospital, Seoul, South Korea

## 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/NCT05304845.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05304845*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*