NCT06308679

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Pharma Nueva · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

Subjects will be fasted at least 10 hours before dosing. After that a single dose of 10-mg Empagliflozin tablets will be administered along with 240 mL of drinking water under fasting condition. In each period, a total of 21 blood samples (approximately 6 mL each) from 21 sampling time points will be collected at pre-dose (6-mL tubes) and at 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 36.00 and 48.00 h post dose. Blood glucose level will be measured at approximately pre-dose, 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00 hours post-dose in each period for subject's safety. During blood sample collection, one drop of blood will be used for this test.

Conditions

• Healthy Vollunteer

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 mg tablets	Empagliflozin 10 mg tablets (test drug)
DRUG	JARDIANCE®	Empagliflozin 10 mg tablets (reference drug)

Timeline

• Start date: 2024-05-28
• Primary completion: 2024-05-31
• Completion: 2024-06-07
• First posted: 2024-03-13
• Last updated: 2024-03-13