Pharmacokinetic bioequivalence and safety assessment of two metformin hydrochloride tablet formulations using a phase I, randomized, open, two-period, two cross-over, single-dose, fed study in healthy Chinese adult subjects.
Int J Clin Pharmacol Ther
; 59(9): 630-638, 2021 Sep.
Article
in En
| MEDLINE
| ID: mdl-34142951
ABSTRACT
OBJECTIVES:
To assess the bioequivalence and safety of generic metformin hydrochloride (test preparation) and glucophage (reference preparation) in healthy Chinese subjects. MATERIALS ANDMETHODS:
A bioequivalence and safety assessment of two formulations of metformin (850 mg) using a randomized, open, two-period, two cross-over, single-dose, fed trial in 36 healthy Chinese adult subjects was performed at our center from March 22, 2018, to April 9, 2018. Bioequivalence was determined as two-sided 90% confidence intervals (CI) of the test-to-reference ratio of area under the curve (AUC) and peak concentration (Cmax) for each constituent within 80.00 - 125.00%. SAS 9.4 software was employed for the statistical analysis.RESULTS:
One subject was excluded from the trial. The 90% CIs (95.36 - 101.43% for AUC0ât, 95.65 - 101.66% for AUC0â∞; 94.43 - 101.74% for Cmax) of test/reference preparation for these pharmacokinetic parameters were within the range of 80.00 - 125.00%. No severe adverse events were observed during this trial. The two preparations were safe and well-tolerated.CONCLUSION:
It was concluded that generic metformin was bioequivalent and as safe as glucophage under fed conditions in healthy Chinese subjects.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Metformin
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Adult
/
Humans
Country/Region as subject:
Asia
Language:
En
Journal:
Int J Clin Pharmacol Ther
Journal subject:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Year:
2021
Document type:
Article