---
title: Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects
nct_id: NCT03016494
overall_status: UNKNOWN
phase: PHASE1
sponsor: Daewoong Pharmaceutical Co. LTD.
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03016494.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03016494"
ct_last_update_post_date: 2017-01-10
last_seen_at: "2026-05-12T06:22:09.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

**Official Title:** A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

**NCT ID:** [NCT03016494](https://clinicaltrials.gov/study/NCT03016494)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 56
- **Lead Sponsor:** Daewoong Pharmaceutical Co. LTD.
- **Conditions:** Healthy
- **Start Date:** 2016-02
- **CT.gov Last Update:** 2017-01-10

## Brief Summary

The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* BMI≥18.5 and ≤27.0 kg/m2
* No clinically significant findings
* Age 19-55 years at screening

Exclusion Criteria:

* Who has allergy to investigational product
```

## Arms

- **Test/Reference Drug** (EXPERIMENTAL) — DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
- **Reference/Test Drug** (EXPERIMENTAL) — co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.

## Interventions

- **Co-administration of DWC20155 and DWC20156** (DRUG)
- **DWJ1386 Tab.** (DRUG)

## Primary Outcomes

- **Maximum Plasma Concentration (Cmax)** _(time frame: 0-24 hours)_
- **Area under the plasma concentration versus time curve (AUC)** _(time frame: 0-24 hours)_

## Locations (1)

- Busan Paik Hospital, Busan, Busanjin-gu, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — 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)_
- `locations.busan paik hospital|busan|busanjin-gu|south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03016494*  
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