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

Sponsored by LG Chem

About this trial

Last updated 6 years ago

Study ID

LG-DMCL008

Status

Unknown status

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Ended 6 years ago

What is this trial about?

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)

What are the participation requirements?

Yes

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

No

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.