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Phase 1Status unknown

A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions

Sponsor
Pharma Nueva (Industry)
Enrolment
28 planned
Conditions
Healthy Vollunteer
Interventions
Empagliflozin 10 mg tablets; JARDIANCE®
Ages
adults
Registry
NCT06308679

Full record on ClinicalTrials.gov

From the registry

Objectives: Primary: to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditions Secondary: To examine the pharmacokinetics and safety of test and reference formulations Study Design: A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions

Primary outcomes

  • Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin
  • Peak Plasma Concentration (Cmax) of Empagliflozin

History

  1. Study completion

  2. Primary completion

  3. Started

  4. Registered