- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03787017
A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs
December 26, 2018 updated by: Handok Inc.
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of FDC of MP-513 20mg and Metformin XR 1000mg With Coadministration of the Two Separate Drugs in Healthy Male Volunteers
The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 20mg and Metformin XR 1000mg with coadministration of the two separate drugs in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Randomized, Open-label, Single-dosing, Two-treatment, Two-sequence, Two-period, crossover design
- Wash-out period : 14days from the first dosing
- Drug concentration analytical device : UPLC-MS/MS
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jung-gu
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Daejeon, Jung-gu, Korea, Republic of, 301-721
- Clinical trials center of Chungnam National University Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
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 < 60mmHg.
- 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 2 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 (more than 21 units/week, 1 unit =10 g of pure 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence Group A
|
Other Names:
Other Names:
Other Names:
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Experimental: Sequence Group B
|
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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(a total of 36 times, with 18 times per period)
|
PK assessment
|
- 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(a total of 36 times, with 18 times per period)
|
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(a total of 36 times, with 18 times per period)
|
PK assessment
|
- 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(a total of 36 times, with 18 times per period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
September 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP_C101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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