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To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

2014-08-27 03:14:06 | BioPortfolio

Summary

This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Conditions

Respiratory Tract Infections

Intervention

Paracetamol 500 mg/Phenylephrine 5 mg tablets, Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Location

Shandon Clinical Trials Ltd.
Cork
Ireland

Status

Completed

Source

Johnson & Johnson Consumer & Personal Products Worldwide

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:06-0400

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Medical and Biotech [MESH] Definitions

An alpha-adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

Sympathetic alpha-adrenergic agonist with actions like PHENYLEPHRINE. It is used as a vasoconstrictor in circulatory failure, asthma, nasal congestion, and glaucoma.

An alpha-adrenergic blocking agent that is used in Raynaud's disease. It is also used locally in the eye to reverse the mydriasis caused by phenylephrine and other sympathomimetic agents. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1312)

A subclass of alpha-adrenergic receptors (RECEPTORS, ADRENERGIC, ALPHA). alpha-1 Adrenergic receptors can be pharmacologically discriminated, e.g., by their high affinity for the agonist phenylephrine and the antagonist prazosin. They are widespread, with clinically important concentrations in the liver, the heart, vascular, intestinal, and genitourinary smooth muscle, and the central and peripheral nervous systems.

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

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