An Open Label, Randomized, Two-period, Two Treatment, Two-sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study to Compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR (Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-release Tablets) 25 mg/5 mg/1000 mg in Fed Condition
Abstract
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fed condition.
Conditions: Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases.
Primary outcome: For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax); For Empagliflozin & Metformin; AUC from time 0 to last collection time (AUC0 - t); For Linagliptin; Area under the plasma concentration-time curve from 0 to 72 hours (AUC72).
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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