Overview

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

Status:
Completed
Trial end date:
2021-12-28
Target enrollment:
0
Participant gender:
All
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 tablets, Marketing Authorisation Holder: Pfizer Europe MA EEIG, Belgium) in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Darnitsa Pharmaceutical Company
Collaborator:
ACDIMA Biocenter
Treatments:
Eplerenone
Criteria
Inclusion Criteria:

1. The subject is Caucasian & aged between eighteen to fifty years (18 - 50), both
inclusive.

2. The subject is within the limits for his height & weight as defined by the body mass
index range (18.5 - 30.0 Kg/m2).

3. The subject is willing to undergo the necessary pre- & post- medical examinations set
by this study.

4. The results of medical history, physical examination, vital signs & conducted medical
laboratory tests are normal as determined by the clinical investigator.

5. The subject tested negative for hepatitis B (HBsAg), hepatitis C (HCVAb), human
immunodeficiency virus (HIVAb) & COVID-19 (PCR) test.

6. 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.

7. The subject is able to understand and willing to sign the informed consent form.

8. 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.

9. The subject has normal cardiovascular system & ECG recording.

10. The subject kidney and liver (AST & ALT enzymes) functions tests are within normal
range.

11. The subject blood pressure is ≥ 110/70 mmHg before dosing.

12. The subject has normal serum creatinine and potassium levels on screening (before 24
hours of admission).

13. The subject HbA1c test result is within normal range.

Exclusion Criteria:

1. Subject is a smoker or an ex-smoker with a non-smoking history of less than 6 months.

2. The subject has suffered an acute illness one week before dosing.

3. The subject has a history of or concurrent abuse of alcohol.

4. The subject has a history of or concurrent abuse of illicit drugs.

5. The subject has a history of hypersensitivity and/or contraindications to the study
drug and any related compounds.

6. The subject has been hospitalized within three months before the study or during the
study.

7. The subject is on special diet (for example subject is vegetarian).

8. 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.

9. 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.

10. The subject has taken grapefruit containing beverages or foodstuffs within seven (7)
days before first dosing and any time during the study.

11. 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.

12. The subject has donated blood within 80 days before first dosing.

13. The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic,
gastrointestinal, hematological, endocrinal, immunological, dermatological,
neurological, musculoskeletal or psychiatric diseases.

14. 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.

15. Pregnant; with positive serum pregnancy test or breast-feeding female subjects.