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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: DA-1229_01; Drug: E+M; Drug: DA-1229_01 fast; Drug: DA-1229_01 fed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02167061

DA1229_01_BE_I

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

(Part 1) DA-1229_01 → E+M

Experimental group

Description:

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

Treatment:

Drug: E+M

Drug: DA-1229_01

(Part 1) E+M → DA-1229_01

Experimental group

Description:

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

Treatment:

Drug: E+M

Drug: DA-1229_01

(Part 2) DA-1229_01 fast → fed

Experimental group

Description:

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

Treatment:

Drug: DA-1229_01 fed

Drug: DA-1229_01 fast

DA-1229_01 fed → fast

Experimental group

Description:

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

Treatment:

Drug: DA-1229_01 fed

Drug: DA-1229_01 fast