Research Article Volume 9 • Issue 4 135 Evaluation of the Bioequivalence of two Linagliptin/Metformin Hydrochloride 2.5/1000 mg Fixed-Dose Combination Tablets in Healthy Adults Under Fed Conditions: A Study from Bangladesh Sabrina Akter Tushi, Md. Ashiqur Rahman, Uttom Kumar Bhowmik, Nayan Ghosh, Nithon Chandra Sahana, Md. Ashraful Islam, Md. Alimur Reza* Affiliation: Novus Clinical Research Services Limited, Dhaka, Bangladesh *Corresponding author: Md. Alimur Reza, Novus Clinical Research Services Limited, Dhaka, Bangladesh. Citation: Sabrina Akter Tushi, Md. Ashiqur Rahman, Uttom Kumar Bhowmik, Nayan Ghosh, Nithon Chandra Sahana, Md. Ashraful Islam, Md. Alimur Reza. Evaluation of the Bioequivalence of two Linagliptin/Metformin Hydrochloride 2.5/1000 mg Fixed-Dose Combination Tablets in Healthy Adults Under Fed Conditions: A Study from Bangladesh. Journal of Pharmacy and Pharmacology Research. 9 (2025): 135-143. Received: October 02, 2025 Accepted: October 08, 2025 Published: October 18, 2025 Abstract Background: Fixed-dose combinations (FDCs) of linagliptin and metformin hydrochloride are commonly used in the treatment of type 2 diabetes mellitus (T2DM) due to their complementary mechanisms of action. Establishing bioequivalence between a generic formulation and an innovator product is essential to ensure comparable safety and efficacy. Aims: To evaluate the bioequivalence of a test formulation of linagliptin and metformin hydrochloride 2.5/1000 mg tablets with the reference product, Trajentamet ® , under fed conditions in healthy adult Bangladeshi subjects. Methods: In this randomized, open-label, two-period, two-sequence, crossover study, healthy volunteers received a single dose of the test or reference product under fed conditions, with a 7-day washout period between doses. Plasma concentrations of linagliptin and metformin were determined using validated LC-MS/MS methods. Pharmacokinetic parameters, including C max , AUC 0-t , and AUC 0-∞ , were calculated. Bioequivalence was assessed using 90% confidence intervals (CIs) for the test-to-reference (T/R) geometric mean ratios, with acceptance criteria of 80%–125%. Statistical analysis was performed using SAS ® software, calculating the ratios of least square means and confidence intervals for primary pharmacokinetic parameters. Results: A total of 24 healthy male subjects (mean age 24.09 ± 3.26 years) completed the study. The T/R ratio of Least Squares Geometric Means and 90% confidence intervals for log-transformed data for C max and AUC measures of Linagliptin and Metformin were within the bioequivalence range of 80%–125%. For Linagliptin, C max was 103.55% and AUC 0-72 was 103.81%. For Metformin, C max was 98.99%, AUC 0-t was 100.45% and AUC 0-∞ was 100.19%, all within the bioequivalence range of 80%–125% for log-transformed values. Statistical analysis (ANOVA) confirmed no significant differences between the formulations, supporting bioequivalence for both drugs. Conclusion: The test formulation of linagliptin and metformin hydrochloride 2.5/1000 mg tablets is bioequivalent to Trajentamet ® under fed conditions in healthy Bangladeshi adults. These findings support its use as a safe and effective alternative in the management of T2DM. Keywords: Bioequivalence, Linagliptin, Metformin, Fixed-dose combination, Type 2 diabetes mellitus, Pharmacokinetics, Trajentamet®, Bangladesh