Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Oral Dose Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study of Empagliflozin 25 mg film coated tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg film-coated tablets of Boehringer Ingelheim International GmbH, Germany in normal, healthy, adult, human subjects under fasting condition.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: Empagliflozin film coated tablets; Drug: Jardiance film-coated tablets

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Navi Mumbai, India
    • Raptim Research Pvt. Ltd.,

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study;

• Willing to be available for the entire study period and to comply protocol requirements;
• Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;
• Body mass index in the range of 18.50 - 30.00 kg/m2 (both inclusive);
• Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period;
• Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
• Normal or clinically non-significant 12-lead ECG recording;
• Non-smokers and willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period;
• Non Alcoholic;
• Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period;
• Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period;
• For female subjects:
• Negative urine pregnancy test during screening and negative serum β-hCG test at the time of check-in of each study period;
• Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use of acceptable birth control methods for at least 15 days before 1st check-in till 15 days post last-dose / entire study period. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].

Exclusion Criteria:

Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;

• Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
• History of diabetes mellitus or insulin resistance.
• Any major illness or hospitalized within 90 days prior to the first check-in;
• Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study;
• Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study;
• Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study;
• History or presence of significant gastric and/or duodenal ulceration;
• Difficulty in swallowing tablets or capsules;
• Use of any recreational drug or history of drug addiction;
• Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in;
• Positive urine alcohol and/or urine drug of abuse tests during check-in of each study period;
• Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
• Lactating or nursing female subjects;
• Female subjects using hormonal contraceptive (either oral/implants);
• History of allergy or hypersensitivity intolerance to Empagliflozin or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study;
• History of difficulty in accessibility of veins in arms.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin film coated tablets; Empagliflozin 25 mg film coated tablets	Drug: Empagliflozin film coated tablets; 1 film coated tablet of 25 mg Empagliflozin; Drug: Jardiance film-coated tablets; 1 film coated tablet of 25 mg Empagliflozin
Active Comparator: Jardiance film-coated tablets; Jardiance (Empagliflozin) 25 mg film-coated tablets	Drug: Empagliflozin film coated tablets; 1 film coated tablet of 25 mg Empagliflozin; Drug: Jardiance film-coated tablets; 1 film coated tablet of 25 mg Empagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration obtained (Cmax)	Two-sided 90% confidence intervals for ratio (test/reference) of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax	48 hours
AUC from the 0 to infinity (AUC0-inf)	Descriptive Statistics	48 hours
Time of the maximum measured plasma concentration (Tmax)	Descriptive Statistics	48 hours

Collaborators and Investigators

• Sponsor: Humanis Saglık Anonim Sirketi
• Investigators: Study Director: Hakan Gürpınar, Humanis Saglık

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2023
• Primary Completion (Actual): August 27, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: PR/BE/22/266

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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