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Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Empagliflozin & Metformin From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)

ClinicalTrials.gov · COMPLETED, 2019

26 participants

Abstract

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Empagliflozin \& Metformin HCL from Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)

Conditions: Healthy.

Primary outcome: Cmax.

Enrollment: 26 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 26 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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