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

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LG Chem

Status and phase

Unknown
Phase 1

Conditions

Type2 Diabetes

Treatments

Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)
Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04070794
LG-DMCL008

Details and patient eligibility

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)

Full 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 healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions

[Admission and Confinement] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in-house stay until 24 hours post-dose.

Fasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

FDC Zemimet® SR Tab. 50/1000(Fasting)
Active Comparator group
Description:
Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fasting condition
Treatment:
Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)
FDC Zemimet® SR Tab. 50/1000(Fed)
Active Comparator group
Description:
Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fed condition
Treatment:
Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)

Trial contacts and locations

0

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Central trial contact

Eunjoo Cho; Sirin Khantichaikajon

Data sourced from clinicaltrials.gov

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