A Bioequivalence and Safety Study of Free Acid Tafamidis 61 mg Capsule and Tablet in Healthy Adults Under Fed Conditions for the Treatment of Transthyretin Amyloidosis

The primary objective of this study is to establish the bioequivalence of the free acid tafamidis 61 mg capsule and tablet. Establishing bioequivalence is essential to ensure that the different dosage forms provide comparable pharmacokinetic profiles. The study will also evaluate the safety and tolerability of the 61 mg tablet in healthy adults under fed conditions in patients with transthyretin amyloidosis.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers of both male and female genders. The participants fall within the age ranges represented by codes 3 and 4. The study involves individuals without transthyretin amyloidosis.

This Phase 2, bioequivalence study is designed to compare the free acid tafamidis 61 mg capsule and tablet in healthy adults under fed conditions. The research methodology involves evaluating the safety and tolerability of the 61 mg tablet. The study protocol includes a screening visit to assess eligibility, followed by scheduled study visits to monitor physiological responses and medication efficacy. The trial concludes with an end-of-study visit. The total duration of the clinical investigation is expected to occur between March 2026 and June 2026. Early termination from the study may occur based on specific clinical criteria or safety protocols.

The assessment of efficacy in this phase 2 clinical trial for transthyretin amyloidosis is not specified in the provided documentation.