Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

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 washout period between the administrations of investigational products of two consecutive periods.

A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Chem
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.