A Randomized, Crossover Bioequivalence Study of Ezetimibe/Atorvastatin 10 mg/80 mg Tablets Versus Film-Coated Tablets in Healthy Volunteers Under Fasting Conditions
- Trial ID
- 2023-504987-40-00
- Protocol
- N-EZEATO-23-277
- Sponsor
- Laboratorios Normon S.A.
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of two formulations of ezetimibe/atorvastatin in **healthy volunteers**. This is clinically relevant as establishing bioequivalence ensures that the two formulations can be used interchangeably, providing flexibility in treatment options and potentially improving patient adherence to therapy. No secondary objectives are specified for this trial.
Participants
The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized under code "3," which typically includes adults. The trial population selection criteria and the total number of participants have not been disclosed by the sponsor. Participants are expected to be in good general health, as indicated by their classification as healthy volunteers. The study does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The trial includes a vulnerable population, although specific details regarding this aspect are not provided. Key inclusion or exclusion criteria have not been detailed by the sponsor.
Plans and Procedures
The clinical trial is designed to evaluate the **bioequivalence** of two formulations of ezetimibe/atorvastatin in **healthy volunteers**. This study is a Phase 2 trial, categorized as a bioequivalence study, and is expected to follow a randomized, double-blind, controlled design. The trial is scheduled to commence recruitment on June 12, 2023, with an estimated completion date of August 14, 2023, indicating a total duration of approximately two months.
Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, potential participants will be assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive one of the two formulations. Throughout the trial, participants will attend follow-up visits at specified intervals to monitor safety, adherence, and any adverse events. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the primary and secondary endpoints of the trial.
The expected length of participant involvement is aligned with the overall trial duration, approximately two months, contingent upon adherence to the study protocol. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of any adverse events that compromise participant safety. The trial is conducted in accordance with ethical standards and regulatory requirements, ensuring the integrity and scientific validity of the study outcomes.
Treatment
In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.
Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on June 12, 2023, with an estimated end date of August 14, 2023. The efficacy assessment will be conducted using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured schedule for measuring and collecting data, adhering to the standards expected in clinical research. The methods for analyzing these efficacy parameters will be consistent with the rigorous requirements of a Phase 2 trial, ensuring that the results are scientifically valid and reliable. The trial will utilize appropriate tools and instruments for efficacy assessments, although specific tools are not mentioned in the available information. The study will be conducted in accordance with the trial phase and category guidelines, ensuring compliance with regulatory standards.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female subjects who, after receiving information about the design, the objectives of the project, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written consent to participate in the study.
- Aged from 18 to 55.
- No clinically significant organic or psychic conditions.
- No clinically significant abnormalities in medical records and physical examination.
- No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis (see Appendix B).
- No clinically significant abnormalities in vital signs and electrocardiogram.
Exclusion Criteria
- Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
- Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- Inability to follow the instructions or collaborate during the study.
- History of difficulty in swallowing.
- Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
- Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
- History of sensitivity to any drug.
- Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
- Smoker.
- Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
- Having donated blood in the last month before start of the study.
- Pregnant or breastfeeding women. Child-bearing age women participating in the study will compromise to use a high effective contraceptive method (see Appendix C) or will be abstinent during their participation in the study.
- Lactose intolerance.
- Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency (failure observed in certain populations of Lapland), or problems absorbing glucose-galactose.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Recruiting | 12 Jun 2023 | 14 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Ezetimiba/Atorvastatina Normogen 10 mg/80 mg comprimidos | Test | TABLET | ORAL USE | 1 | 1 | PRD10333489 |
ATOZET 10 mg/80 mg comprimidos recubiertos con película | Comparator | COMPRIMIDOS RECUBIERTOS CON PELÍCULA | ORAL USE | 1 | 1 | PRD8835287 |