Bioequivalence Study of Two Hydrochlorothiazide Formulations in Healthy Volunteers
- Trial ID
- 2023-505692-72-00
- Protocol
- N-HID-23-279
- Sponsor
- Laboratorios Normon S.A.
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of two formulations of **hydrochlorothiazide** 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 and outcomes.
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 was selected to include a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet, physical activity, or habits are not provided. The sponsor has not disclosed the total number of participants involved in the study. Key inclusion or exclusion criteria are not specified in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the **bioequivalence** of two formulations of **hydrochlorothiazide** in **healthy volunteers**. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the investigators are aware of which formulation is being administered, thus minimizing bias. The trial is categorized under Phase 2, indicating that it is focused on assessing the efficacy and side effects of the formulations in a controlled environment. The estimated recruitment start date is June 19, 2023, with the trial expected to conclude by August 4, 2023, marking a total duration of approximately seven weeks.
Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment to ensure that only **healthy volunteers** are enrolled. Following successful screening, participants will be randomized to receive one of the two formulations. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health status, adherence to the study protocol, and any adverse events. These visits are crucial for collecting data on the pharmacokinetics and pharmacodynamics of the formulations.
The end-of-study visit will occur at the conclusion of the trial period, where final assessments will be conducted to evaluate the overall outcomes and any long-term effects. The expected length of participant involvement is approximately seven weeks, aligning with the overall trial duration. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.
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 19, 2023, with an estimated end date of August 4, 2023. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments. The study will be conducted in accordance with regulatory requirements and ethical guidelines to ensure the integrity of the data collected.
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 with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption.
- 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.
- Wheat starch hypersensitivity.
- Subjects with anuria.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Recruiting | 19 Jun 2023 | 30 |
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 |
|---|---|---|---|---|---|---|
Esidrex 25 mg comprimidos | Comparator | COMPRIMIDOS | ORAL USE | 1 | 1 | PRD5018665 |
Hidroclorotiazida Normon 25 mg comprimidos | Test | TABLET | ORAL USE | 1 | 1 | PRD10373871 |