Randomised, crossover bioequivalence clinical trial of pregabalin 300 mg tablets versus pregabalin 300 mg hard capsules, after a single oral dose administration to healthy volunteers under fasting conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501160-18-00

Acronym

N-PRE-22-273

Enrollment

Registered

2022-09-19

Start date

2022-09-22

Completion date

2022-10-27

Last updated

2022-09-19

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

Conditions

Healthy volunteers

Brief summary

AUC0-t, Cmax

Detailed description

AUC0-∞, Tmax

Interventions

DRUGLyrica 300 mg hard capsules

DRUGPregabalina Normon 300 mg comprimidos

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
AUC0-t, Cmax	—

Secondary

Measure	Time frame
AUC0-∞, Tmax	—

Countries

Spain

Outcome results

None listed

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