A randomised, two-period two-stage cross-over study on the relative bioavailability of two different liquid formulations of single noscapine doses (phase I/IV, open-label) in healthy volunteers (fasted state) - Trial DRKS00017760
Access comprehensive clinical trial information for DRKS00017760 through Pure Global AI's free database. This Phase 1 trial is sponsored by InfectoPharm Arzneimittel und Consilium GmbHDr. Bertil WachallVon-Humboldt-Str. 164646 HeppenheimGermany and is currently Recruitment Completed. The study focuses on None ;Healthy volunteers.
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Study Focus
Interventional
Sponsor & Location
InfectoPharm Arzneimittel und Consilium GmbHDr. Bertil WachallVon-Humboldt-Str. 164646 HeppenheimGermany
Timeline & Enrollment
Phase 1
N/A
N/A
Summary
The aim of the present study is to demonstrate bioequivalence between the approved noscapin-containing Nipaxon® 5 mg / ml (oral suspension) and a new formulation of the suspension. For this purpose, both substances are each administered orally once, while maintaining a 6-14 days washout phase. Bioequivalence is determined by comparison of the relative bioavailability of both substances. Both preparations differ only in their formulation, but not in the concentration of the active ingredient.
ICD-10 Classifications
Data Source
Deutsches Register Klinischer Studien
DRKS00017760
Non-Device Trial