HEALTHCARE PROFESSIONALS

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 [Takeda]).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 6.0 September 2023.
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DEPENDABLE SUPPLY CHAIN.
For further information please call: 01730 231148,
email: [email protected] or visit www.aspirepharma.co.uk
Adverse events should be reported. Reporting forms and information can be found at:

Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148.www.mhra.gov.uk/yellowcard

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

Revision reference – Gatalin XL_28_20.02.2024

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