A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787017
• Other study ID #: MP_C101
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2018
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

1. Randomized, Open-label, Single-dosing, Two-treatment, Two-sequence, Two-period, crossover design

2. Wash-out period : 14days from the first dosing

3. Drug concentration analytical device : UPLC-MS/MS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• FDC(MP-513 20mg/Metformin XR 1000mg)

• MP-513 20mg

• Metformin XR 1000mg

Locations

Country	Name	City	State
Korea, Republic of	Clinical trials center of Chungnam National University Hospital	Daejeon	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of MP-513 and metformin	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)
Primary	Cmax of MP-513 and metformin	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)