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

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ClinicalTrials.gov Identifier: NCT03787043
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: FDC(MP-513 10mg/Metformin XR 750mg) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence Group A
  1. 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted
  2. 2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fed
Drug: FDC(MP-513 10mg/Metformin XR 750mg)
Other Name: HL1511

Experimental: Sequence Group B
  1. 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fed
  2. 2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted
Drug: FDC(MP-513 10mg/Metformin XR 750mg)
Other Name: HL1511




Primary Outcome Measures :
  1. AUC of MP-513 and metformin [ Time Frame: 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) ]
    PK

  2. Cmax of MP-513 and metformin [ Time Frame: 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) ]
    PK



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787043


Locations
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Korea, Republic of
Clinical trials center of Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of, 301-721
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.

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Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03787043     History of Changes
Other Study ID Numbers: MP_C102
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
Food Effect

Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs