An open label, randomized, single-dose, two-sequence, two-period, crossover comparative bioavailability study to assess the pharmacokinetic and safety profile of Dofetilide intravenous solution compared to Tikosyn® (Dofetilide) oral capsule in healthy subjects under fasting conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510176-31-00

Acronym

D052019

Enrollment

Registered

2024-07-03

Start date

2024-07-22

Completion date

2024-11-04

Last updated

2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

a single-dose, crossover bioavailability study comparing IV to oral Dofetilide., open label, randomized, This study is a phase I trial, two-period, two-sequence

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Countries

Bulgaria

Outcome results