Comparative Bioavailability and Bioequivalence of Oxazepam 10 mg Orodispersible Tablets (Test) Versus Seresta® 10 mg Tablets (Reference): A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501134-35-00

Acronym

LESVIOXA/22/BQ-2

Enrollment

Registered

2022-10-24

Start date

2022-10-26

Completion date

2022-11-13

Last updated

2022-10-24

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

Conditions

No medical condition is being investigated. This is a comparative bioavailabilty study.

Brief summary

Cmax and AUC0-t of oxazepam will be the primary pharmacokinetic parameters.

Detailed description

Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs, and clinical laboratory tests, Palatability of test product will be assessed approximately 30 seconds and 5 minutes after placing the ODT on the tongue.

Interventions

DRUGOxazepam

DRUGSERESTA 10 mg

DRUGcomprimé

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Cmax and AUC0-t of oxazepam will be the primary pharmacokinetic parameters.	—

Secondary

Measure	Time frame
Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs, and clinical laboratory tests, Palatability of test product will be assessed approximately 30 seconds and 5 minutes after placing the ODT on the tongue.	—

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026