To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
Status and phase
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Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy male and female
- Caucasians
- Aged between 18 and 50 years
- BMI ≤ 30 kg/m2
- Clinically normal medical history
- Physical normal examination
- Normal laboratory test results
Exclusion criteria
- Pregnancy, lactation or intended pregnancy
- Hypersensitivity to or intolerant of the study medications
- Donation or loss of blood within 90 days preceding the first dose of study medication
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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