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

NCT06308679 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-03-13

No results posted yet for this study

Summary

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

Conditions

  • Healthy Vollunteer

Interventions

DRUG

Empagliflozin 10 mg tablets

Empagliflozin 10 mg tablets (test drug)

DRUG

JARDIANCE®

Empagliflozin 10 mg tablets (reference drug)

Sponsors & Collaborators

  • Pharma Nueva

    lead INDUSTRY

Principal Investigators

  • Porranee Puranajoti · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2024-05-31
Completion
2024-06-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06308679 on ClinicalTrials.gov