A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Evaluate the Effect of Food on the Safety and Pharmacokinetics of Fixed-dose Combination of MP-513 10mg and Metformin XR 750mg in Healthy Male Volunteers

The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed state versus fasting state to healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: FDC(MP-513 10mg/Metformin XR 750mg)

Detailed Description

1. Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover design
2. Wash-out period: 14 days from the first dosing
3. Drug concentration analytical device: UPLC-MS/MS

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 301-721
      • Clinical trials center of Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening test.
• Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW) within ±20%
• An individual who has been given and fully understood detailed explanations about this study, decides to participate in the study of his own will, and provides written informed consent to comply with instructions.

Exclusion Criteria:

• History or presence of any clinically significant diseases in the hepatobiliary, renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular, urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and, particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).
• History of any gastrointestinal disease that may affect absorption of the study drug (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy or hernia repair).
• Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same class as ingredients or to other drugs
• Vital signs in a sitting position corresponding to at least one of the following criteria: systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure ≥ 95 mmHg or < 60 mmHg.
• Serum creatine > upper limit of reference range
• Required to refrain from food intake for at least 24 hours during the study period due to surgery or religious reason.
• History or presence of drug abuse.
• Administration of drugs that either induce or inhibit drug metabolizing enzymes, such as barbitals, within 1 month prior to the first dosing.
• Intake of food or beverage containing grapefruit or cranberry within 1 week prior to the first dosing.
• Administration of any ethical drugs or traditional Korean herbal medicines within 2 weeks or any over-the-counter drugs or vitamin products within 1 week prior to the first dosing
• An individual who participated in another clinical trial and was administered any investigational product within 3 months prior to the first dosing.
• Whole blood donation within 2 months, apheresis donation within 1 month, or blood transfusion within 1 month prior to the first dosing.
• An individual who drinks excessive amounts of alcohol or who cannot stop drinking alcohol from 24 hours prior to hospital admission through to hospital discharge.
• Having smoked 10 cigarettes/day or more on average over the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Group A; 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted; 2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fed	Drug: FDC(MP-513 10mg/Metformin XR 750mg); Other Names: HL1511
Experimental: Sequence Group B; 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fed; 2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted	Drug: FDC(MP-513 10mg/Metformin XR 750mg); Other Names: HL1511

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of MP-513 and metformin	PK	0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)
Cmax of MP-513 and metformin	PK	0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)

Collaborators and Investigators

• Sponsor: Handok Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Food Effect
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: MP_C102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES