None listed
Conditions
Brief summary
This is a Phase I pilot study designed to evaluate the pharmacokinetic profile of fixed dose combinations of paracetamol 325 mg, and phenylephrine hydrochloride at doses between 2.5 and 2.9 mg per tablet, when given as two tablets per dose. The results of this study will guide the selection of the further dose strength of phenylephrine hydrochloride to be used in a fixed dose combination with paracetamol 325 mg, which will be further evaluated in a larger confirmatory pharmacokinetic study.
Interventions
12 healthy participants will be randomly allocated, in a five-way cross-over manner, to the following treatments:
Treatment A: 650 mg paracetamol and 5 mg phenylephrine hydrochloride
Treatment B: 650 mg paracetamol and 5.2 mg phenylephrine hydrochloride
Treatment C: 650 mg paracetamol and 5.4 mg phenylephrine hydrochloride
Treatment D: 650 mg paracetamol and 5.6 mg phenylephrine hydrochloride).
Treatment E: 650 mg paracetamol and 5.8 mg phenylephrine hydrochloride
Each of the treatment will be a
12 healthy participants will be randomly allocated, in a five-way cross-over manner, to the following treatments: Treatment A: 650 mg paracetamol and 5 mg phenylephrine hydrochloride Treatment B: 650 mg paracetamol and 5.2 mg phenylephrine hydrochloride Treatment C: 650 mg paracetamol and 5.4 mg phenylephrine hydrochloride Treatment D: 650 mg paracetamol and 5.6 mg phenylephrine hydrochloride). Treatment E: 650 mg paracetamol and 5.8 mg phenylephrine hydrochloride Each of the treatment will be administered orally, as a single dose. The administration of the study drugs is done under the supervision of the study staff. There will be a washout period of 7 days between each of the study treatments Participants will be required to fast overnight (for at least 10 hours) before dosing and for 4 hours thereafter.
Sponsors
AFT Pharmaceuticals Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects, males and females aged 18 to 40 years of age. Females must be infertile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 3 days before the start of each study phase, with the exception of oral contraceptives and the study medication. All subjects must be deemed healthy on the basis of a medical history, physical exam, urinalysis, and blood biochemical and haematological examinations.
Exclusion criteria
- Women who are pregnant or nursing - Women of childbearing potential who are unwilling to take adequate contraceptive precautions - Women of childbearing potential who are unwilling to undergo a urine pregnancy test - Have any history of allergy or hypersensitivity to paracetamol and phenylephrine hydrochloride - Have a history of drug abuse or positive test results for drug abuse during screening. - Be able and willing to abstain from all prescription and over-the-counter medications (excluding the study drug and oral contraceptive) and herbal remedies for the duration of the study.
Outcome results
None listed