NCT06308679

UnknownPhase 1

A Bioequivalence Study of Two Formulations of 10-mg Empaglif...

Pharma Nueva Source

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Other study identifiers

Sponsor study identifier

BE 001-24

Study Type

interventional

Estimated enrollment

28

Locations

0 countries

Sites

N/A

Timeline

Study Start

May 28, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

May 31, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 7, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 28 participants
Study completion date: June 7, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 6, 2024
Actual (reported)
First Posted
March 13, 2024
Actual (reported)
Study Start
May 28, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 7, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 13, 2024
Status Verified: March 2024
Last Update Submitted: March 6, 2024

Conditions

Healthy Vollunteer

Keywords

EmpagliflozinBioequivalence 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 tabletsDrug: JARDIANCE®

ARDIANCE®

ACTIVE COMPARATOR

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

Drug: Empagliflozin 10 mg tabletsDrug: JARDIANCE®

Interventions

Empagliflozin 10 mg tabletsDrug

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

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Pharma Nueva
Industrylead

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

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

May 31, 2024

Estimated (date passed)

Phase 1

Active Not Recruiting

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Phase 1Recruiting

SYFd56d214e59c947139f4b57c9ed3ba237

Comparative Bioavailability of Empagliflozin 25 mg Film-Coated Tablets: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting Conditions.

Phase 1Unknown

NCT06962826

A Study in Healthy People to Test How Empagliflozin is Taken up in the Body When Taken as a Whole Tablet or Dissolved in Water and Mixed With Food

Phase 1Completed

NCT05360615

The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors

Phase 1Active Not Recruiting

NCT05614115

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

Phase 1Completed

NCT05960656

SGLTi, Hepatic Glucose Production and Ketogenesis

Phase 1Recruiting

ARDIANCE®

Generic Empagliflozin 10 mg tablets

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

+1 more criteria

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

Contact the study team to confirm eligibility.

thanaporn.won@mahidol.ac.th

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 7, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06308679
Data provider: ClinicalTrials.gov
Source updated: 2024-03-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:04 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Generic Empagliflozin 10 mg tablets

ARDIANCE®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record