---
title: A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State
nct_id: NCT03944200
overall_status: COMPLETED
phase: PHASE1
sponsor: Dong-A ST Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Type2 Diabetes
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03944200.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03944200"
ct_last_update_post_date: 2020-05-20
last_seen_at: "2026-05-12T07:19:37.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State

**Official Title:** Randomized, Open Label, Single Oral Administration at Fed State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)

**NCT ID:** [NCT03944200](https://clinicaltrials.gov/study/NCT03944200)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Dong-A ST Co., Ltd.
- **Conditions:** Type2 Diabetes
- **Start Date:** 2019-02-07
- **Completion Date:** 2019-03-25
- **CT.gov Last Update:** 2020-05-20

## Brief Summary

A study demonstrates the bioequivalence of DA-1229\_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults

## Eligibility

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

```
Inclusion Criteria:

* Adult patients over 19 years of age at the time of health examination
* Female patients who were confirmed to be not pregnant at health examination
* Patients without a history of mental illness in the past 5 years

Exclusion Criteria:

* Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
* Patients with a congestive heart failure which requires medicinal treatment
* Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
* Female patients who are lactating
```

## Arms

- **Test drug, Reference drug group** (EXPERIMENTAL) — Period 1: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar.

The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
- **Reference drug,Test drug group** (ACTIVE_COMPARATOR) — Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.

The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar.

## Interventions

- **DA-1229_01(A), Sugamet SR Tab 5/1000mg®** (DRUG) — Period 1: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar.

The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
- **Sugamet SR Tab 5/1000mg®, DA-1229_01(A)** (DRUG) — Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.

The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar.

## Primary Outcomes

- **Area under the concentration-time curve(AUCt)** _(time frame: Hour -1 ~ Hour 24)_ — AUCt of metformin
- **Maximum plasmaconcentration of drug in plasma(Cmax)** _(time frame: Hour -1 ~ Hour 24)_ — Cmax of metformin

## Secondary Outcomes

- **Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)** _(time frame: Hour -1 ~ Hour 24)_
- **AUCt/AUCinf** _(time frame: Hour -1 ~ Hour 24)_
- **Time to reach the maximum plasma concentration(Tmax)** _(time frame: Hour -1 ~ Hour 24)_
- **Terminal elimination rate constant(ramda z)** _(time frame: Hour -1 ~ Hour 24)_
- **Terminal elimination half-life(t1/2)** _(time frame: Hour -1 ~ Hour 24)_

## Locations (1)

- Metro Hospital, Anyang-si, Gyeonggi-do, 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.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — 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.metro hospital|anyang-si|gyeonggi-do|south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03944200*  
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