Comparative Bioavailability Study of Amlodipine/Valsartan/Hydrochlorothiazide Versus Reference in Healthy Subjects Under Fasting Conditions

The primary objective of this study is to evaluate the **bioavailability** of a test product, Amlodipine/Valsartan/Hydrochlorothiazide 10 mg/160 mg/12.5 mg film-coated tablets, in comparison to the reference product, Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets. This assessment is conducted in healthy male and female subjects under fasting conditions. The clinical relevance of this objective lies in determining the pharmacokinetic equivalence between the test and reference formulations, which is crucial for ensuring therapeutic efficacy and safety in clinical practice.

The clinical trial involves a study population that includes both **male** and **female** participants. The age range of the participants falls within the category code "3," which typically corresponds to adults. The trial population includes a vulnerable population, although specific details regarding the nature of this vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. The trial is focused on bioavailability, and as such, no specific medical condition is being targeted. Information regarding the selection process for participants, as well as any lifestyle considerations such as diet, physical activity, or habits, has not been provided by the sponsor. Key inclusion or exclusion criteria are also not specified in the available data.

The clinical trial is designed as a **randomized**, open-label, replicated single-dose, 4-period, 2-sequence crossover study. The primary aim is to assess the comparative **bioavailability** of a test product, Amlodipine/Valsartan/Hydrochlorothiazide 10 mg/160 mg/12.5 mg film-coated tablets, against a reference product, Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets, in healthy male and female subjects under fasting conditions. The trial is categorized under Phase 2 and is expected to commence recruitment on September 15, 2025, with an estimated completion date of December 4, 2025.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as the screening phase to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the two sequences for the crossover study. Each participant will receive both the test and reference products in a randomized order across four periods, with adequate washout intervals between doses to prevent carryover effects. The study will include follow-up visits to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the trial, where final assessments and data collection will occur.

The expected length of participant involvement is determined by the duration of the crossover periods and the washout intervals, typically spanning several weeks. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is structured to ensure rigorous data collection and analysis, adhering to ethical standards and regulatory requirements.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the study may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the provided data, further details about the experimental and non-experimental treatments, including their administration and monitoring, cannot be elaborated upon. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, indicating its focus on evaluating the efficacy and side effects of the intervention. The trial is scheduled to commence recruitment on September 15, 2025, with an estimated completion date of December 4, 2025. The specific parameters or endpoints used to evaluate efficacy, as well as the methods and schedule for measuring, collecting, and analyzing these parameters, are not detailed in the provided data. The trial's primary and secondary endpoints, along with any tools or instruments involved in efficacy assessments, are not specified. The trial's design and execution will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments.