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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Vollunteer
• Intervention / Treatment: Drug: Empagliflozin 10 mg tablets; Drug: JARDIANCE®

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Thanaporn Wongyai; Phone Number: 024415211; Email: thanaporn.won@mahidol.ac.th
• Study Contact Backup: Name: Aksorn Jarupintusopon; Phone Number: 0918744146; Email: aksorn.riengsilchai@pharmanueva.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Thai male and/or female age between 18-55 years
2. Has body mass index (BMI) between 18.0-30.0 kg/m2
3. 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
4. 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
5. Has negative result for Hepatitis B viral profile (HBsAg)
6. Has normal or acceptable report (being assessed as not clinically significant by the clinical investigator) for EKG
7. Male subjects agree to use effective contraceptive from screening visit to the follow-up visit.
8. 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 2.
9. 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.
10. Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)).
11. Non-smokers (never smoked or no smoking within the previous 1 year)
12. Refrain from using herbal medications, cannabis containing products, dietary supplements (e.g., St. John's Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 2.
13. Subjects must have ended the systematic medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow-up period.
14. Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period 2.
15. Has ability and intention to comply with the requirement of study and available for the whole study period
16. Willing to participate and voluntarily signed the informed consent form prior to participate the study

Exclusion Criteria:

1. Known hypersensitivity to empagliflozin and/or related structure and/or its constituents.
2. 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.
3. Alcohol abuse or excessive use (more than 1 time/week) in the last 12 months
4. Alcohol breath test at screening visit or before admission show alcohol concentration more than 0.000 %BAC.
5. History of drug abuse or urine sample shows a positive test for Morphine, Tetrahydrocannabinol and Methamphetamine at screening visit or before admission.
6. Following a special diet (e.g., vegetarian) or dieting one month before the study initiation.
7. A pregnant woman (positive pregnancy test at screening or prior to dosing in each period) or woman in breast feeding period
8. 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
9. 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)
10. Has blood donated within last 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Generic Empagliflozin 10 mg tablets; Generic Empagliflozin 10 mg tablets (test drug)	Drug: Empagliflozin 10 mg tablets; Empagliflozin 10 mg tablets (test drug); Drug: JARDIANCE®; Empagliflozin 10 mg tablets (reference drug); Other Names: Empagliflozin 10 mg tablets
Active Comparator: ARDIANCE®; ARDIANCE® (Empagliflozin 10 mg tablets (reference drug))	Drug: Empagliflozin 10 mg tablets; Empagliflozin 10 mg tablets (test drug); Drug: JARDIANCE®; Empagliflozin 10 mg tablets (reference drug); Other Names: Empagliflozin 10 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin	Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin	Through 48 hours post dose
Peak Plasma Concentration (Cmax) of Empagliflozin	Peak Plasma Concentration (Cmax) of Empagliflozin	48 hours post dose

Collaborators and Investigators

• Sponsor: Pharma Nueva
• Investigators: Principal Investigator: Porranee Puranajoti, International Bio service

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 7, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Empagliflozin; Bioequivalence study
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: BE 001-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No