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Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

NCT06180109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-12-22

No results posted yet for this study

Summary

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study of Empagliflozin 25 mg film coated tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg film-coated tablets of Boehringer Ingelheim International GmbH, Germany in normal, healthy, adult, human subjects under fasting condition.

Conditions

  • Type2 Diabetes Mellitus

Interventions

DRUG

Empagliflozin film coated tablets

1 film coated tablet of 25 mg Empagliflozin

DRUG

Jardiance film-coated tablets

1 film coated tablet of 25 mg Empagliflozin

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Hakan Gürpınar · Humanis Saglık

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2023-08-27
Completion
2023-10-06

Countries

  • India

Study Locations

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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 NCT06180109 on ClinicalTrials.gov