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

Pharma Nueva0 sites28 target enrollmentMay 28, 2024

ConditionsHealthy Vollunteer

InterventionsEmpagliflozin 10 mg tablets JARDIANCE®

DrugsEmpagliflozin 10 mg tablets JARDIANCE®

Overview

Phase: Phase 1
Intervention: Empagliflozin 10 mg tablets
Conditions: Healthy Vollunteer
Sponsor: Pharma Nueva
Enrollment: 28
Primary Endpoint: Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 28, 2024

End Date

June 7, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pharma Nueva

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Thai male and/or female age between 18-55 years
•Has body mass index (BMI) between 18.0-30.0 kg/m2
•Has been determined healthy by physical examination, assessment of medical history, and vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 139 mmHg, diastolic blood pressure not lower than 60 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians
•Has normal or acceptable results (being assessed as not clinically significant by the clinical investigator) for all screening tests including: Complete Blood Count (CBC), Fasting Blood Sugar (FBS), Aspartate Aminotransferase (AST or SGOT), Alanine Aminotransferase (ALT or SGPT), Alkaline Phosphatase (ALP), Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine (Cr), Potassium, Sodium, Chloride, Phosphate and Urinalysis
•Has negative result for Hepatitis B viral profile (HBsAg)
•Has normal or acceptable report (being assessed as not clinically significant by the clinical investigator) for EKG
•Male subjects agree to use effective contraceptive from screening visit to the follow-up visit.
•Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing at screening and prior to dosing at period 1 and period
•Female subjects who is childbearing potential and using effective non-hormonal contraceptive methods (e.g., condom, diaphragm, cervical cap or sexual abstinence) or total abstinence from sexual intercourse from screening visit to the follow-up visit.
•Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)).

Exclusion Criteria

•Known hypersensitivity to empagliflozin and/or related structure and/or its constituents.
•Has history or concurrent symptoms of cardiovascular, gastrointestinal, hematological disorders, renal and hepatic impairment and/or any disease that may affect the bioavailability of the drug.
•Alcohol abuse or excessive use (more than 1 time/week) in the last 12 months
•Alcohol breath test at screening visit or before admission show alcohol concentration more than 0.000 %BAC.
•History of drug abuse or urine sample shows a positive test for Morphine, Tetrahydrocannabinol and Methamphetamine at screening visit or before admission.
•Following a special diet (e.g., vegetarian) or dieting one month before the study initiation.
•A pregnant woman (positive pregnancy test at screening or prior to dosing in each period) or woman in breast feeding period
•A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to dosing and during the entire period of the study and/or using injected, intrauterine and implanted hormonal methods of contraception within 3 months prior to dosing and during the entire period of the study
•A participant in any investigation drug study within last 30 days prior to screening (from the last visit that received medication to the screening visit)
•Has blood donated within last 2 months