Clinical Data Gatalin2020-03-23T16:45:03+00:00

HEALTHCARE PROFESSIONALS
GatNewBanner

Clinical Data

Gatalin® XL meets all the relevant regulatory requirements of a bioequivalent medicine (UK reference product Reminyl® (galantamine) XL 8mg, 16mg and 24mg prolonged-release capsules [Shire Pharmaceuticals, UK]).1 Three bioequivalence clinical trials were performed comparing Reminyl XL 8mg prolonged-release capsules with Gatalin XL 8mg prolonged-release capsules. Two single dose studies were performed under fed and fasted conditions and a steady state study was performed under fasted conditions. The graphs are shown below.

Single-dose study comparing Gatalin XL 8mg and Reminyl XL 8mg under fasting conditions

Single-dose study comparing Gatalin XL 8mg and Reminyl XL 8mg under fed conditions

Steady-state study comparing Gatalin XL 8mg and Reminyl XL 8mg under fasting conditions

References: 1) Data on file. 1010067149 v 4.0 October 2019.
TRUSTED BRANDS.
DEPENDABLE SUPPLY CHAIN.
For further information please call: 01730 231148,
email: info@aspirepharma.co.uk or visit www.aspirepharma.co.uk
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148

For more information about Gatalin XL, please see the abbreviated prescribing information.

Revision reference – Gatalin XL_23_23.03.2020

More products available
in this range:
Click to view their
individual websites