HEALTHCARE PROFESSIONALS

Clinical Data

Biquelle® XL meets all the relevant regulatory requirements of a bioequivalent medicine (UK reference product Seroquel® XR (quetiapine) 50mg, 150mg, 200mg, 300mg and 400mg prolonged-release tablets [AstraZeneca, London, UK]).1 Four bioequivalence clinical studies were performed.1 One single-dose, randomized crossover study compared Biquelle XL 50mg prolonged-release tablets with Seroquel XR 50mg prolonged-release tablets under fasted conditions. Two single-dose, randomized crossover studies compared Biquelle XL 200mg prolonged-release tablets with Seroquel XR 200mg prolonged-release tablets under fed and fasted conditions.1 One steady-state study compared Biquelle XL 400mg prolonged-release tablets with Seroquel XR 400mg prolonged-release tablets under fasted conditions.1

Single-dose study comparing Biquelle XL 50mg and Seroquel XR 50mg under fasted conditions.1

Single-dose study comparing Biquelle XL 200mg and Seroquel XR 200mg under fed conditions

Single-dose study comparing Biquelle XL 200mg and Seroquel XR 200mg under fasted conditions

Steady-state study comparing Biquelle XL 400mg and Seroquel XR 400mg under fasted conditions

References: 1) Data on file. 1010067149 v 4.0 October 2019.
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DEPENDABLE SUPPLY CHAIN.
For further information please call: 01730 231148,
email: customerservices@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 Biquelle XL, please see the abbreviated prescribing information.

Revision reference – Biquelle XL_18_03.05.21

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