Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers

NCT06337409 | Not Yet Recruiting Phase 1

• 1 other identifier: BE24-004
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions

Conditions

Healthy Volunteer

Keywords

Empagliflozin 25 mg Film-coated Tablets

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax period

  Bioequivalence based on Cmax period

  Through 72 Hours Post Dose

Secondary Outcomes (1)

• Bioequivalence based on AUC parameters

  Through 72 Hours Post Dose

Study Arms (2)

Empagliflozin 25 mg film-coated tablets

EXPERIMENTAL

The test product, generic empagliflozin 25 mg film-coated tablets, will be formulated using the same active ingredient with the same strength as the reference product, JARDIANCE®. The test product to be used in this bioequivalence study is prepared in accordance with GMP regulations.

Drug: Generic empagliflozin 25 mg film-coated tablets

Empagliflozin 25 mg film-coated tablets, JARDIANCE

ACTIVE COMPARATOR

Empagliflozin 25 mg film-coated tablets, JARDIANCE®, has been registered with Food and Drug Administration, Thailand (TFDA).

Drug: Generic empagliflozin 25 mg film-coated tablets

Interventions

Generic empagliflozin 25 mg film-coated tablets DRUG

Empagliflozin 25 mg film-coated tablets

Also known as: Empagliflozin

Empagliflozin 25 mg film-coated tablets; Empagliflozin 25 mg film-coated tablets, JARDIANCE

Eligibility Criteria

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

You may qualify if:

• Healthy Thai male or female subjects between the ages of 18 to 55 years
• Body mass index between 18.5 to 30.0 kg/m2.
• Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study
• Non-pregnant woman (negative pregnancy test) and not currently breast feeding
• Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
• Postmenopausal for at least 1 year or
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
• Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
• Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

You may not qualify if:

• History of allergic reaction or hypersensitivity to empagliflozin or to any of the excipients.
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness.
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19.
• History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
• Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening
• History or evidence of type 1 diabetes mellitus or diabetic ketoacidosis.
• History or evidence of heart failure.
• History or evidence of volume depletion or hypotension.
• History or evidence of genital mycotic infections, urinary tract infections within 14 days prior to check-in in each period.
• History or evidence of necrotizing fasciitis of the perineum (fournier's gangrene).
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
• History of problems with swallowing tablet or capsule.
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy.
• History of diarrhea or vomiting within 24 hours prior to check-in in each period

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

empagliflozin

Study Officials

• Uthai Suvanakoot, Ph. D

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweena Boonprakong

CONTACT

024415211; paweena.bon@mahidol.ac.th

Thanaporn Wongyai, B.Sc.Pharm

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: July 1, 2024
• Primary Completion: July 5, 2024
• Study Completion: July 13, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share