Comparative Bioavailability Study of Intravenous vs. Oral Dofetilide in Healthy Subjects Under Fasting Conditions

The primary objective of this study is to evaluate the **pharmacokinetic** and safety profile of Dofetilide intravenous solution compared to Tikosyn® (Dofetilide) oral capsule in healthy subjects under fasting conditions. This is clinically relevant as it aims to determine the bioavailability of the intravenous formulation relative to the established oral form, which could inform dosing strategies and therapeutic applications for conditions such as atrial fibrillation. The study is designed as an open label, randomized, single-dose, two-sequence, two-period, crossover trial, which allows for a direct comparison of the two formulations in the same subjects, thereby minimizing inter-subject variability.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range categorized as adults. The trial does not include a vulnerable population. The study is a phase I trial focusing on the bioavailability of **Dofetilide**, comparing intravenous to oral administration. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed. The selection process for the trial population remains unspecified.

The clinical trial is designed as an **open label**, randomized, single-dose, two-sequence, two-period, crossover comparative bioavailability study. The primary objective is to assess the pharmacokinetic and safety profile of **Dofetilide** intravenous solution compared to Tikosyn® (Dofetilide) oral capsule in healthy subjects under fasting conditions. The trial is categorized as a phase I study, focusing on the comparison of intravenous to oral administration of Dofetilide. The estimated recruitment start date is June 20, 2024, with an anticipated end date of August 5, 2024, indicating a relatively short trial duration.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of two sequences for the crossover study. Each participant will receive a single dose of the investigational product in one period and the comparator in the other, with a washout period in between. Follow-up visits will be scheduled to monitor pharmacokinetic parameters and safety outcomes. The end-of-study visit will conclude the trial, where final assessments will be conducted to ensure participant safety and collect any remaining data.

The expected length of participant involvement is approximately two months, encompassing the screening, dosing, washout, and follow-up phases. 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 study is structured to ensure rigorous data collection and analysis, adhering to ethical standards and regulatory requirements.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these treatments cannot be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the data. As such, these details cannot be elaborated upon in this context.

The clinical trial is designed to assess the efficacy of the investigational treatment in a Phase 3 study. The trial is scheduled to commence recruitment on June 20, 2024, with an estimated completion date of August 5, 2024. The efficacy of the treatment will be evaluated using predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy assessments.