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A Randomized, Open label, Single Center, Single Oral Dose, Four Treatment, Four Period, Four Sequence, Crossover Bioavailability Study of Haleon Immediate Release Tablets 2X (paracetamol/naproxen 500 mg/125 mg) vs. Panadol Advance Tablets 2X (paracetamol 500 mg), Naprosyn Tablets 1X (naproxen 250 mg), administered individually in fasted conditions and Haleon Immediate Release Tablets 2X (paracetamol/naproxen 500 mg/125 mg) in fed conditions in Healthy Adult Participants

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524663-20-00
Enrollment
52
Registered
2026-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-06

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

Conditions

Healthy volunteers, therapeutic indication not studied

Brief summary

AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively

Detailed description

AUC0-tlast, Cmax and tmax for paracetamol and naproxen after administration of Test under fasted vs. Test under fed conditions, Tmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol after fasted administration of Reference 1, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for naproxen after fasted administration of Reference 2, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol and naproxen after administration of Test, under fasted and fed condition, Tolerability assessment based on AEs, vital signs and protocol-specified safety labs for Test and Reference treatments.

Interventions

DRUGPanadol Advance 500 mg Tablets
DRUGParacetamol 500 mg and Naproxen 125mg Tablet MFC-06285
DRUGNaprosyn 250 mg comprimidos

Sponsors

Haleon CH SARL
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively

Secondary

MeasureTime frame
AUC0-tlast, Cmax and tmax for paracetamol and naproxen after administration of Test under fasted vs. Test under fed conditions, Tmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol after fasted administration of Reference 1, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for naproxen after fasted administration of Reference 2, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol and naproxen after administration of Test, under fasted and fed condition, Tolerability assessment based on AEs, vital signs and protocol-specified safety labs for Test and Reference treatments.

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 7, 2026