Healthy VolunteersPhase 1NCT03787017
A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs
A Phase 1 study testing FDC(MP-513 20mg/Metformin XR 1000mg), MP-513 20mg and Metformin XR 1000mg in people with Healthy Volunteers, run by Handok Inc. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- FDC(MP-513 20mg/Metformin XR 1000mg), MP-513 20mg and Metformin XR 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical trials center of Chungnam National University Hospital
Daejeon, Jung-gu, 301-721
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- FDC(MP-513 20mg/Metformin XR 1000mg), MP-513 20mg, Metformin XR 1000mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC(MP-513 20mg/Metformin XR 1000mg)Drug
Also called HL1351
MP-513 20mgDrug
Also called Tenelia 20mg
Metformin XR 1000mgDrug
Also called Glucophage XR 1000mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence Group A | Experimental | 1. 1st period : coadministration of 1 tablet of MP-513 20mg and 1 tablet of Metformin XR 1000mg, single-dose under fasted
2. 2nd period : 1 tablet of FDC(MP-513 20mg/Metformin XR 1000mg), single-dose under fasted Receives: Drug: FDC(MP-513 20mg/Metformin XR 1000mg); Drug: MP-513 20mg; Drug: Metformin XR 1000mg |
| Sequence Group B | Experimental | 1. 1st period : 1 tablet of FDC(MP-513 20mg/Metformin XR 1000mg), single-dose under fasted
2. 2nd period : coadministration of 1 tablet of MP-513 20mg and 1 tablet of Metformin XR 1000mg, single-dose under fasted Receives: Drug: FDC(MP-513 20mg/Metformin XR 1000mg); Drug: MP-513 20mg; Drug: Metformin XR 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of MP-513 and metformin
PK assessment
Measured: - 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
PK assessment
Measured: - 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study startJan 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787017
- Sponsor's protocol ID
- MP_C101
- Status last verified
- Dec 2018
- First submitted
- 5 Oct 2015
- Last updated
- 27 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03787017
- Acronym / sponsor ID
- MP_C101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence Group A | Experimental | Drug: FDC(MP-513 20mg/Metformin XR 1000mg), Drug: MP-513 20mg, Drug: Metformin XR 1000mg1. 1st period : coadministration of 1 tablet of MP-513 20mg and 1 tablet of Metformin XR 1000mg, single-dose under fasted 2. 2nd period : 1 tablet of FDC(MP-513 20mg/Metformin XR 1000mg), single-dose under fasted |
| Sequence Group B | Experimental | Drug: FDC(MP-513 20mg/Metformin XR 1000mg), Drug: MP-513 20mg, Drug: Metformin XR 1000mg1. 1st period : 1 tablet of FDC(MP-513 20mg/Metformin XR 1000mg), single-dose under fasted 2. 2nd period : coadministration of 1 tablet of MP-513 20mg and 1 tablet of Metformin XR 1000mg, single-dose under fasted |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDC(MP-513 20mg/Metformin XR 1000mg)Also: HL1351 | Drug | Sequence Group A, Sequence Group B |
| MP-513 20mgAlso: Tenelia 20mg | Drug | Sequence Group A, Sequence Group B |
| Metformin XR 1000mgAlso: Glucophage XR 1000mg | Drug | Sequence Group A, Sequence Group B |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FDC(MP-513 20mg/Metformin XR 1000mg), MP-513 20mg and Metformin XR 1000mg in people with Healthy Volunteers, run by Handok Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.