Status:
COMPLETED
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
Lead Sponsor:
LG Chem
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of correspo...
Eligibility Criteria
Inclusion
- Body mass index between 18.0 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding
- Female subjects abstain from either hormonal methods of contraception
- Male subjects who are willing or able to use effective contraceptive
- Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
Exclusion
- History serious hypersensitivity reactions
- History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
- History or evidence of family diabetes
- History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
- History or evidence of shock or severe dehydrate or severe infection
- History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period
- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
- History of problems with swallowing tablet or capsule
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Any condition possibly affecting drug absorption
- Have renal creatinine clearance (Clcr) \< 45 mL/min based on serum creatinine results at the screening laboratory test
- 12-lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04317703
Start Date
August 19 2020
End Date
September 5 2020
Last Update
February 9 2021
Active Locations (1)
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1
International Bio Service Co., Ltd.
Nakhon Pathom, Thailand