A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Metformin Hydrochloride 850 mg relative to Glucophage 850 mg in healthy Thai volunteers under fed condition

Authors
Category Primary study
Registry of TrialsTCTR
Year 2023
INTERVENTION: Experimental Drug,Active Comparator Drug Metformin Hydrochloride 850 mgFilm‐coated Tablet ,Glucophage 850 mg The new generic products which were recently developed. Volunteer will receive a single dose of Metformin Hydrochloride 850 mg) Film‐coated Ta of either test or reference with 250 mL of 20% glucose solution in water ,The marketed original products which were already available in the market. Volunteer will receive a single dose of Glucophage 850 mg either test or reference with 250mL of 20% glucose solution in water CONDITION: Bioequivalence Metformin Hydrochloride 850 mg Film‐coated Tablet Healthy subjects ; Bioequivalence Metformin Hydrochloride 850 mg Film‐coated Tablet PRIMARY OUTCOME: Cmax AUC0‐t and AUC0‐inf pre‐dose (0.00 hour) and at 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours Pharmacokinetics parameter SECONDARY OUTCOME: Safety; Adverse events 1.0, 2.0, 4.0, 8.0, 12.0 and 24.0 hours Safety monitoring, vital sign INCLUSION CRITERIA: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai subjects are between 18 to 55 years of age. 3. The Body Mass Inde X(BMI) ranges from 18.5 to 30 kg/m2. 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects safety after the completion of the study. 5. Negative urine pregnancy test for women and no breast‐feeding. 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
Epistemonikos ID: c18ff7755df118a35eaca32710c00ba64ee481cf
First added on: Feb 20, 2024