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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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

DA-1229_01

E+M

DA-1229_01 fast

DA-1229_01 fed

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Clinical Trial Center, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

(Part 1) DA-1229_01 → E+M

(Part 1) E+M → DA-1229_01

(Part 2) DA-1229_01 fast → fed

DA-1229_01 fed → fast

Arm Description

DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Outcomes

Primary Outcome Measures

Area Under Curve(AUC)last of Evogliptin and Metformin

Maximum of concentration (Cmax) of Evogliptin and Metformin

Secondary Outcome Measures

Time of maximum concentration(Tmax) of Evogliptin and Metformin

Terminal half-life(t1/2) of Evogliptin and Metformin

Apparent Clearance(CL/F) of Evogliptin and Metformin

Area Under Curve(AUC)inf of Evogliptin and Metformin

AUCinf = AUC last + Clast/λz

Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)

Full Information

NCT ID

NCT02167061

First Posted

June 11, 2014

Last Updated

November 27, 2014

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02167061

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

(Part 1) DA-1229_01 → E+M

Arm Type

Experimental

Arm Description

DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

Arm Title

(Part 1) E+M → DA-1229_01

Arm Type

Experimental

Arm Description

DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

Arm Title

(Part 2) DA-1229_01 fast → fed

Arm Type

Experimental

Arm Description

DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Arm Title

DA-1229_01 fed → fast

Arm Type

Experimental

Arm Description

DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Intervention Type

Drug

Intervention Name(s)

DA-1229_01

Other Intervention Name(s)

Evogliptin/Metformin XR 5/1000 mg

Intervention Description

complex single administration

Intervention Type

Drug

Intervention Name(s)

E+M

Other Intervention Name(s)

Evogliptin 5 mg + Metformin XR 1000 mg

Intervention Description

co-administration of 2 drugs

Intervention Type

Drug

Intervention Name(s)

DA-1229_01 fast

Intervention Type

Drug

Intervention Name(s)

DA-1229_01 fed

Primary Outcome Measure Information:

Title

Area Under Curve(AUC)last of Evogliptin and Metformin

Time Frame