Pill identifier metformin 500 mg
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Pill Identifier: Metformin 500 mg
Bioequivalence of Metformin 500 mg Tablets
Bioequivalence Studies
Bioequivalence studies are essential to ensure that generic drugs have the same efficacy and safety as their branded counterparts. Several studies have evaluated the bioequivalence of different brands of metformin 500 mg tablets.
A study comparing the bioequivalence of two metformin hydrochloride sustained-release (MH-SR) tablets, Boke® and Glucophage®-XR, in healthy Chinese volunteers found that the 90% confidence intervals (CIs) for key pharmacokinetic parameters were within the acceptable range of 80.00–125.00%1. This indicates that both formulations are bioequivalent and safe under fasting conditions.
Similarly, another study assessed the bioavailability of two brands of metformin 500 mg tablets, Dialon® and Glucophage®, in healthy male volunteers. The results showed that the pharmacokinetic parameters, including AUC0–t, AUC0–∞, and Cmax, were within the bioequivalence acceptance range of 80–125%3. This confirms that Dialon® is bioequivalent to Glucophage®.
Pharmacokinetic Parameters
Pharmacokinetic parameters such as the area under the curve (AUC) and maximum concentration (Cmax) are crucial in determining bioequivalence. In the study comparing Boke® and Glucophage®-XR, the adjusted geometric mean ratios (GMRs) for AUC0–t, AUC0–∞, and Cmax were 97.36–108.30%, 97.26–108.09%, and 96.76–111.37%, respectively1. These values fall within the bioequivalence range, indicating similar absorption and efficacy.
Another study involving the comparison of Metformin Hydrochloride (SR) 500 mg tablet and Dibeta SR tablet also found that the Cmax, AUC0–t, and AUC0–∞ values were within the acceptable range of 80–125%4. This further supports the bioequivalence of different metformin formulations.
Safety and Adverse Effects
Adverse Drug Reactions
Safety is a critical aspect of bioequivalence studies. In the study comparing Boke® and Glucophage®-XR, no severe adverse events were observed. However, 38 adverse drug reactions (ADRs) were reported, including metabolic or nutritional conditions, infections, gastrointestinal conditions, and abnormal inspections1. The incidence of ADRs was similar between the two formulations, indicating comparable safety profiles.
Metformin in PCOS Treatment
Metformin is also used in the treatment of polycystic ovary syndrome (PCOS). A study comparing metformin and ethinyl estradiol-cyproterone acetate in obese women with PCOS found that metformin significantly decreased waist-to-hip ratio, serum testosterone, fasting free fatty acid, and insulin concentrations2. This suggests that metformin can improve ovarian function and glucose metabolism in women with PCOS.
Conclusion
In conclusion, multiple studies have demonstrated the bioequivalence and safety of various metformin 500 mg tablet formulations. These findings ensure that generic alternatives can be used effectively and safely, providing more options for patients. Additionally, metformin's role in treating conditions like PCOS further highlights its therapeutic versatility.
Sources and full results
Most relevant research papers on this topic
Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke® and Glucophage®-XR) in healthy Chinese volunteers: a randomized phase I clinical trial
Both generic metformin hydrochloride sustained-release tablets (Boke®) and the innovator product (Glucophage®-XR) are bioequivalent and safe under fasting conditions in healthy Chinese participants.
RCTEndocrine and metabolic effects of metformin versus ethinyl estradiol-cyproterone acetate in obese women with polycystic ovary syndrome: a randomized study.
Metformin improves glucose metabolism and menstrual cyclicity in obese women with PCOS, while Diane Nova is effective for women with hyperandrogenism and hirsutism.
RCT
Highly CitedBioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon® & Glucophage®) – in healthy human volunteers
Dialon® and Glucophage® are bioequivalent in terms of metformin 500 mg tablet bioavailability in healthy male volunteers.
RCTBioavailability and pharmacokinetic study of Metformin 500 mg tablet (SR formulations) in healthy human volunteers
The test formulation of Metformin 500 mg tablet (SR) is bioequivalent to the reference standard in terms of bioavailability and pharmacokinetics in healthy human volunteers.
RCTAdherence, satisfaction, and experience with metformin 500 mg prolonged release formulation in Indian patients with type 2 diabetes mellitus: a postmarketing observational study
The technologically advanced metformin 500 mg PR tablet is more effective than the extended-release tablet in improving adherence, compliance, satisfaction, and perception in Indian patients with type 2 diabetes mellitus.
Observational Study
Rigorous JournalBioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers
The test formulation of glimepiride/metformin (2/500 mg) fixed-dose combination tablets met the Korean regulatory criteria for bioequivalence in healthy male adult volunteers.
RCTThe Potency of Some Brands of Anti-Diabetic Medicine- Metformin Hydrochloride B.P 500 mg Tablet on the Ghanaian Market
All seven brands of metformin hydrochloride tablet BP 500mg on the Ghanaian market passed the test for assay, dissolution rate, and uniformity of weight, meeting the British Pharmacopoeia (BP) monograph.
Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial.
Metformin effectively lowers fasting plasma glucose and HbA1c levels in type II diabetes patients, with benefits observed as low as 500 mg and maximal benefits at the upper recommended daily dosage, all well-tolerated.
RCT
Large Human TrialHighly CitedPharmacokinetic comparison of gemigliptin 50 mg and metformin 500 mg as a fixed-dose combination and loose combination .
The fixed-dose combination of gemigliptin 50 mg and metformin 500 mg shows similar pharmacokinetic profiles and safety as the loose combination, with no clinically meaningful differences in safety and tolerability.
RCTPharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover
The new glimepiride/metformin 1/500 mg SR tablet and the glimepiride/metformin 2/500 mg SR tablet show dose-proportional characteristics of glimepiride and comparable pharmacokinetic properties of metformin.
RCT