AN OPEN LABEL, TWO PERIODS, TWO SEQUENCES, CROSSOVER, RANDOMIZED MULTIPLE DOSE BIOEQUIVALENCE STUDY OF GUANFACINE 7 MG PROLONGED-RELEASE TABLETS (TEST FORMULATION) VS. EQUAL DOSE OF INTUNIV® PROLONGED-RELEASE TABLETS (REFERENCE FORMULATION) IN HEALTHY MALE VOLUNTEERS UNDER FASTING CONDITIONS

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506596-10-00

Acronym

GFC-BEMD-01-NXP/23

Enrollment

Registered

2024-01-19

Start date

2024-01-31

Completion date

2024-05-13

Last updated

2024-01-19

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

Conditions

Study performed on healthy volunteers.

None listed

Sex/Gender

Male

Age

18 Years to 64 Years

Romania

None listed

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