Empagliflozin 10 mg Tablets Relative to Jardiance 10 mg

Sponsor
Bio-innova Co., Ltd
Study ID
NCT06232239
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin-Test product — DRUG
    Empagliflozin 10 mg tablets Test product Manufactured by: Thai Meiji Pharmaceuticals Co., Ltd., Thailand
  • Empagliflozin-Reference product — DRUG
    Empagliflozin 10 mg tablets Reference product Manufactured by: Boehringer Ingelheim Pharma Gmbh \& Co. Kg, Germany

Study Details

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 7 days washout period between the doses.

Key Dates

Start date
Feb 27, 2024
Status verified
Jan 2024
Primary completion
Apr 5, 2024
Completion
Apr 19, 2024

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sequence 1- Empagliflozin test product and then reference product
    Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Empagliflozin Tablets 10 mg test product, treatment 2= Empagliflozin Tablets 10 mg reference product.
  • Experimental: Sequence 2-Empagliflozin reference product and then test product
    Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Empagliflozin Tablets 10 mg test product, treatment 2= Empagliflozin Tablets 10 mg reference product.

Primary Outcome Measure

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) [ Time Frame: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose ]

Central Contacts

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