Type2 Diabetes MellitusPhase 1NCT06180109
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
A Phase 1 study testing Empagliflozin film coated tablets and Jardiance film-coated tablets in people with Type2 Diabetes Mellitus, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Empagliflozin film coated tablets and Jardiance film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jul 2023to 6 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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)].
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Empagliflozin film coated tablets, Jardiance film-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin film coated tabletsDrug
1 film coated tablet of 25 mg Empagliflozin
Jardiance film-coated tabletsDrug
1 film coated tablet of 25 mg Empagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin film coated tablets | Experimental | Empagliflozin 25 mg film coated tablets Receives: Drug: Empagliflozin film coated tablets; Drug: Jardiance film-coated tablets |
| Jardiance film-coated tablets | Active comparator | Jardiance (Empagliflozin) 25 mg film-coated tablets Receives: Drug: Empagliflozin film coated tablets; Drug: Jardiance film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
AUC from the 0 to infinity (AUC0-inf)
Descriptive Statistics
Measured: 48 hours
Time of the maximum measured plasma concentration (Tmax)
Descriptive Statistics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start30 Jul 2023
- Primary completion27 Aug 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hakan Gürpınar, Study director, Humanis Saglık
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180109
- Sponsor's protocol ID
- PR/BE/22/266
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06180109
- Acronym / sponsor ID
- PR/BE/22/266
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin film coated tablets | Experimental | Drug: Empagliflozin film coated tablets, Drug: Jardiance film-coated tabletsEmpagliflozin 25 mg film coated tablets |
| Jardiance film-coated tablets | Active comparator | Drug: Empagliflozin film coated tablets, Drug: Jardiance film-coated tabletsJardiance (Empagliflozin) 25 mg film-coated tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin film coated tablets1 film coated tablet of 25 mg Empagliflozin | Drug | Empagliflozin film coated tablets, Jardiance film-coated tablets |
| Jardiance film-coated tablets1 film coated tablet of 25 mg Empagliflozin | Drug | Empagliflozin film coated tablets, Jardiance film-coated tablets |
Primary outcome
Maximum concentration obtained (Cmax)
Time frame: 48 hours
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
AUC from the 0 to infinity (AUC0-inf)
Time frame: 48 hours
Descriptive Statistics
Time of the maximum measured plasma concentration (Tmax)
Time frame: 48 hours
Descriptive Statistics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Gürpınar study director
Humanis Saglık
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Empagliflozin film coated tablets and Jardiance film-coated tablets in people with Type2 Diabetes Mellitus, run by Humanis Saglık Anonim Sirketi at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration obtained (Cmax) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.