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

NCT06308679 | Not Yet Recruiting Phase 1

• 1 other identifier: BE 001-24
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Vollunteer

Keywords

Empagliflozin; Bioequivalence study

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Generic Empagliflozin 10 mg tablets

EXPERIMENTAL

Generic Empagliflozin 10 mg tablets (test drug)

Drug: Empagliflozin 10 mg tablets; Drug: JARDIANCE®

ARDIANCE®

ACTIVE COMPARATOR

ARDIANCE® (Empagliflozin 10 mg tablets (reference drug))

Drug: Empagliflozin 10 mg tablets; Drug: JARDIANCE®

Interventions

Empagliflozin 10 mg tablets DRUG

Empagliflozin 10 mg tablets (test drug)

ARDIANCE®; Generic Empagliflozin 10 mg tablets

JARDIANCE® DRUG

Empagliflozin 10 mg tablets (reference drug)

Also known as: Empagliflozin 10 mg tablets

ARDIANCE®; Generic Empagliflozin 10 mg tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 2.
• 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)).
• Non-smokers (never smoked or no smoking within the previous 1 year)
• 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.
• 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.
• 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.
• Has ability and intention to comply with the requirement of study and available for the whole study period

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharma Nueva: lead

MeSH Terms

Interventions

empagliflozin

Study Officials

• Porranee Puranajoti

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aksorn Jarupintusopon

CONTACT

0918744146; aksorn.riengsilchai@pharmanueva.com

Thanaporn Wongyai

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: May 28, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 7, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share