Status:
UNKNOWN
Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
Lead Sponsor:
LG Chem
Conditions:
Type2 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days wa...
Detailed Description
\[Objectives\] Primary: To investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in hea...
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 such as respiratory tract infection, urinary tract infection within 14 days prior to admission in each period
- 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
- Difficulty fasting or consuming standardized meals
- 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 :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04070794
Start Date
November 1 2019
End Date
December 30 2019
Last Update
August 28 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.