Pharmacokinetic study of acetaminophen and ibuprofen, oral formulations, in healthy volunteers under fed conditions

Single-centre, single-dose, open-label, randomised, three-period cross-over study to evaluate the pharmacokinetic parameters of acetaminophen and ibuprofen fixed dose oral combinations, acetaminophen with tramadol hydrochloride, fixed dose oral combination and ibuprofen oral formulation in healthy volunteers, under fed conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000317493

Enrollment

Registered

2016-03-10

Start date

2016-03-27

Completion date

2016-04-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is designed as a Phase 1 trial to evaluate the pharmacokinetic profile of different doses of acetaminophen and ibuprofen administered orally to 30 healthy volunteers and evaluate the effect of food on the pharmacokinetic profile

Interventions

Each participant will be randomly allocated to receive a single dose of each of the following treatments in a balanced three-way cross-over sequence: Treatment A: 975 mg acetaminophen and 292.5 mg ibuprofen Treatment B: 650 mg acetaminophen and 75 mg tramadol hydrochloride Treatment C: 800 mg ibuprofen. All treatments will be administered as oral tablets, with a full glass of water, in fed conditions. The administration of all doses will be supervised on site. The washout period between the periods is 3 days. Dose frequency - single dose, administered as oral tablets. All participants complete all three periods (treatments A-C) in a cross-over fashion. Participants will be fasted for at least 10 hours overnight before dosing and receive a standardized breakfast served 30 minutes prior to study drug administration. This breakfast will supply around 967kcal about 50% of which are fat calories. A standardized meal will be provided approximately at 5 hours after dosing. Also a snack will be provided approximately at 9 hours after the study drug administration. Meal plans will be identical in all periods and will be served at the same time. Water will be restricted for 1 hour pre-dose and 1 hour post-dose.

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, excess alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal laboratory tests

Outcome results