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

Sponsor
Pharma Nueva
Study ID
NCT06308679
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy Vollunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin 10 mg tablets — DRUG
    Empagliflozin 10 mg tablets (test drug)
  • JARDIANCE® — DRUG
    Empagliflozin 10 mg tablets (reference drug)

Study Details

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

Key Dates

Start date
May 28, 2024
Status verified
Mar 2024
Primary completion
May 31, 2024
Completion
Jun 7, 2024

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Generic Empagliflozin 10 mg tablets
    Generic Empagliflozin 10 mg tablets (test drug)
  • Active Comparator: ARDIANCE®
    ARDIANCE® (Empagliflozin 10 mg tablets (reference drug))

Primary Outcome Measure

Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin [ Time Frame: Through 48 hours post dose ]

Central Contacts