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BioequivalencePhase 1NCT05663372

Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers

A Phase 1 study testing Efez 50 mg eplerenone film-coated tablets and INSPRA® 50 mg eplerenone film-coated tablets in people with Bioequivalence and Healthy Subjects, run by Darnitsa Pharmaceutical Company at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal product INSPRA® 50 mg eplerenone film-coated… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Bioequivalence, Healthy Subjects
What is being tested?
Efez 50 mg eplerenone film-coated tablets and INSPRA® 50 mg eplerenone 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 siteJordan
Study dates
7 Dec 2021to 28 Dec 2021
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is Caucasian \& aged between eighteen to fifty years (18 - 50), both inclusive.
  • The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
  • The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
  • The results of medical history, physical examination, vital signs \& conducted medical laboratory tests are normal as determined by the clinical investigator.
  • The subject tested negative for hepatitis B (HBsAg), hepatitis C (HCVAb), human immunodeficiency virus (HIVAb) \& COVID-19 (PCR) test.
  • There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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  • The subject is able to understand and willing to sign the informed consent form.
  • For female subjects: a negative pregnancy test must be confirmed, and if sexually active, at least 4 weeks of highly effective contraceptive method must be used prior to IMP administration and throughout the study progress until last visit; highly effective methods comprise hormonal contraceptives, intrauterine devices IUDs, sexual abstinence or vasectomized partner (success of vasectomy was medically proven). For subjects using a hormonal contraceptive method, a barrier form of contraception should be combined with the hormonal contraception.
  • The subject has normal cardiovascular system \& ECG recording.
  • The subject kidney and liver (AST \& ALT enzymes) functions tests are within normal range.
  • The subject blood pressure is ≥ 110/70 mmHg before dosing.
  • The subject has normal serum creatinine and potassium levels on screening (before 24 hours of admission).
  • The subject HbA1c test result is within normal range.

Who cannot join

  • Subject is a smoker or an ex-smoker with a non-smoking history of less than 6 months.
  • The subject has suffered an acute illness one week before dosing.
  • The subject has a history of or concurrent abuse of alcohol.
  • The subject has a history of or concurrent abuse of illicit drugs.
  • The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
  • The subject has been hospitalized within three months before the study or during the study.
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  • The subject is on special diet (for example subject is vegetarian).
  • The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 36 hours after dosing in all study periods.
  • The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
  • The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
  • The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
  • The subject has donated blood within 80 days before first dosing.
  • The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
  • The subject has consumed drugs or foodstuffs that may affect pharmacological or pharmacokinetic properties of eplerenone (for example: strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir), potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene), ACE inhibitors and angiotensin II receptor antagonists, lithium or NSAIDs) two weeks before dosing, during the study and two weeks after dosing.
  • Pregnant; with positive serum pregnancy test or breast-feeding female subjects.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • ACDIMA Center for Bioequivalence and Pharmaceutical Studies

    Amman, 11190

Other trials in Jordan

About this study

Official title: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Efez 50 mg Eplerenone Film-coated Tablets Versus INSPRA® 50 mg Eplerenone Film-coated Tablets, in Healthy Adult Male and Female Subjects Under Fasting Conditions

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal product INSPRA® 50 mg eplerenone film-coated tablets, Marketing Authorisation Holder: Pfizer Europe MA EEIG, Belgium) in healthy volunteers.

Being tested
Efez 50 mg eplerenone film-coated tablets, INSPRA® 50 mg eplerenone film-coated tablets
Keywords
bioequivalence, eplerenone, healthy subjects, pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efez 50 mg eplerenone film-coated tabletsDrug

    Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone

  • INSPRA® 50 mg eplerenone film-coated tabletsDrug

    Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone

Study groups in NCT05663372
Study groupRoleWhat they receive
Efez (Test)ExperimentalA single oral dose of the test product Efez 50 mg eplerenone film-coated tablets.
Receives: Drug: Efez 50 mg eplerenone film-coated tablets
INSPRA®Active comparatorA single oral dose of the reference product INSPRA® 50 mg eplerenone film-coated tablets.
Receives: Drug: INSPRA® 50 mg eplerenone film-coated tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum plasma concentration (Cmax)

    The Cmax value is based on the eplerenone plasma concentration.

    Measured: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose.

  2. Area under the concentration-time curve from time zero to the last quantifiable concentration (t)

    The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on the eplerenone plasma concentration.

    Measured: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start7 Dec 2021
  3. Primary completion28 Dec 2021
  4. Study completion28 Dec 2021

Resources

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
Model description
Two-period, two-sequence, two-way, crossover, single dose study
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663372
Sponsor's protocol ID
EPL01-E
Status last verified
Dec 2022
First submitted
15 Dec 2022
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Efez 50 mg eplerenone film-coated tablets and INSPRA® 50 mg eplerenone film-coated tablets in people with Bioequivalence and Healthy Subjects, run by Darnitsa Pharmaceutical Company at 1 site in Jordan.

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 13 inclusion and 15 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 23 Dec 2022. 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 Jordan. 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 plasma concentration (Cmax) (time frame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663372.

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 23 Dec 2022.

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