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OpenTrials
Completed

NCT Number: NCT04317703

Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

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 corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

International Bio Service Co., Ltd.

Nakhon Pathom, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Gemigliptin tartrate sesquihydrate and metformin

Drug

Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.

Other names: Zemimet® SR Tab. 50/1000 mg

gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release

Drug

Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.

Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base).

Other names: Zemiglo Tablet 50 mg and Glucophage XR 1000 mg

Primary outcomes

  1. bioequivalence study

    Time frame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 32.00 and 48.00 hours post-dose

    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 corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose, Two-way Crossover Bioequivalence Study of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) and Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage® XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) Under Fasting Conditions in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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