A Phase 1 interventional study of Paracetamol 500 mg/Phenylephrine 5 mg tablets and Paracetamol 1000 mg/Phenylephrine 10 mg sachet in Respiratory Tract Infections, sponsored by McNeil AB. Completed at 1 site in Ireland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by McNeil AB · Phase 1, Interventional, and Basic science
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 40 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →McNeil AB is the lead sponsor of 41 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Paracetamol 500 mg/Phenylephrine 5 mg tablet
Drug: Paracetamol 500 mg/Phenylephrine 5 mg tablets
Paracetamol 1000 mg/Phenylephrine 10 mg sachet
Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachet
2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
Also known as: Sudafed PE Sinus Pain Relief™
1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period
Also known as: Flu Plus Hot Lemon™ sachet
Pharmacokinetic measurements
Pharmacokinetic measurements including: * Cmax (Maximum concentration) * AUC0-t (Area under the plasma concentration versus time curve from 0h to the lastmeasurable concentration) * AUC0-inf (Area under the plasma concentration versus time curve from 0h to infinity)
Time frame: during 24 hours following drug administration
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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McNeil AB