Bioequivalence study of 1000 mg Metformin HCl extended release caplet manufactured by PT. Hexpharm Jaya (Nevox XR 1000 mg Caplet) for Formula A and Formula B in comparison with 1000 mg Glucophage® XR extended release tablet manufactured by Merck Sante SAS, France, imported by PT. Merck Indonesia Tbk., Jakarta

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-LPAEZM
Tanggal Input Registry : 10-05-2022

09-10-2021
To investigate whether 1000 mg Metformin HCl extended release caplet manufactured by PT. Hexpharm Jaya (Nevox XR 1000 mg Caplet) for Formula A and Formula B is bioequivalent to its reference product, 1000 mg Glucophage® XR extended release tablet manufactured by Merck Sante SAS, France, imported by PT. Merck Indonesia Tbk., Jakarta.
NA
 
Bioequivalence study of 1000 mg Metformin HCl extended release caplet manufactured by PT. Hexpharm Jaya (Nevox XR 1000 mg Caplet) for Formula A and Formula B in comparison with 1000 mg Glucophage® XR extended release tablet manufactured by Merck Sante SAS, France, imported by PT. Merck Indonesia Tbk., Jakarta
Bioequivalence study of 1000 mg Metformin HCl extended release caplet manufactured by PT. Hexpharm Jaya (Nevox XR 1000 mg Caplet) for Formula A and Formula B in comparison with 1000 mg Glucophage® XR extended release tablet manufactured by Merck Sante SAS, France, imported by PT. Merck Indonesia Tbk., Jakarta
Eksperimental
Subjects were given a single dose of 1 extended release caplet of the test drug (Nevox XR 1000 mg Caplet formula A or formula B) or 1 extended release tablet of the reference drug (Glucophage® XR extended release 1000 mg Tablet) under fasted condition. The drug was administered with 240 ml of 20% glucose solution in water.
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Inclusion Criteria:

The inclusion criteria were healthy subjects who/with: -had read the subject information and signed informed consent documents -healthy male and female -age range from 18 – 55 years -body mass index between 18 – 25 kg/m2 -had a normal electrocardiogram -had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg) -had the heart rate within normal range (60 – 100 bpm) -with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening -acceptance to use contraceptive device for female and acceptance to use contraceptive device during the entire study period for male subjects

Exclusion Criteria:

This study was not eligible for: -pregnant and/or nursing condition -those with a history of hypersensitivity to metformin, other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction -those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g., chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. -those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. -those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. -those who have participated in any clinical study within 3 months prior to the study (< 90 days). -those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study. -those who were smoke more than 10 cigarettes a day. -those with a history of travelling to another city within the last 14 days -those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood -those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days -those who positive to SARS CoV-2 antigen test -those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential). -those with a history of drug or alcohol abuse within 12 months prior to screening for this study. -those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1058/UN2.F1/ETIK/PPM.00.02/2020
NA
RG.01.02.321.09.21.00340/UB
557/STD/PML/2020
Olivia Valencia