A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers

A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02167061

Enrollment

Registered

2014-06-18

Start date

2014-07-31

Completion date

2014-11-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 and to investigate the effect of food on the pharmacokinetics of DA-1229\_01 in healthy male volunteers

Interventions

DRUGDA-1229_01

complex single administration

DRUGE+M

co-administration of 2 drugs

DRUGDA-1229_01 fast

DRUGDA-1229_01 fed

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 20 to 45, healthy male subjects(at screening) * Body weight between 55kg - 90kg, BMI between 18.0 - 27.0 * FPG 60-125mg/dL glucose level(at screening) * Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion criteria

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder) * Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) * Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction * Subject who already participated in other trials in 2 months * Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Design outcomes

Primary

Measure	Time frame
Area Under Curve(AUC)last of Evogliptin and Metformin	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Maximum of concentration (Cmax) of Evogliptin and Metformin	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Secondary

Measure	Time frame	Description
Apparent Clearance(CL/F) of Evogliptin and Metformin	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose	—
Time of maximum concentration(Tmax) of Evogliptin and Metformin	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose	—
Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose	—
Area Under Curve(AUC)inf of Evogliptin and Metformin	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose	AUCinf = AUC last + Clast/λz
Terminal half-life(t1/2) of Evogliptin and Metformin	1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026