None listed
Conditions
Brief summary
This study is designed as a Phase I trial to evaluate the pharmacokinetic profile of different doses of acetaminophen and ibuprofen administered orally to 30 healthy adult volunteers in fasting conditions.
Interventions
Each participant will be randomly allocated to receive a single dose of each of the following three treatments, as oral tablets, in a balanced, three-ways cross-over sequence:
Treatment A: 975 mg acetaminophen + 292,5 mg ibuprofen
Treatment B: 650 mg acetaminophen + 75 mg tramadol hydrochloride
Treatment C: 800 mg ibuprofen
All treatments will be administered as oral tablets with a full glass of water. The administration of the doses will be supervised on site, Participants will be required to f
Each participant will be randomly allocated to receive a single dose of each of the following three treatments, as oral tablets, in a balanced, three-ways cross-over sequence: Treatment A: 975 mg acetaminophen + 292,5 mg ibuprofen Treatment B: 650 mg acetaminophen + 75 mg tramadol hydrochloride Treatment C: 800 mg ibuprofen All treatments will be administered as oral tablets with a full glass of water. The administration of the doses will be supervised on site, Participants will be required to fast overnight at least 10 hours before dosing and four hours thereafter, The washout period between periods is 3 days, The dose frequency is single dose. All participants complete all three periods treatment A-C in a cross-over fashion.
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 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers, males and females aged 18 to 50 years of age. Females must be sterile 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 7 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 (including vital signs and ECG recording), urinalysis, and blood biochemical and haematological examinations.
Exclusion criteria
Pregnancy, nursing, drug abuse, smoking>10 cigarettes per day, alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests.
Outcome results
None listed