Pharmacokinetic study of paracetamol and ibuprofen, solution for infusion, in healthy volunteers

Single-centre, single-dose, open-label, randomised, five-way cross-over study to evaluate the pharmacokinetic parameters of intravenously administered combination of paracetamol and ibuprofen, intravenous paracetamol, intravenous ibuprofen and fixed dose combination tablets of paracetamol and ibuprofen, in healthy volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000809639

Acronym

AFT-MXIV-01

Enrollment

Registered

2014-07-30

Start date

2014-09-18

Completion date

2014-11-10

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

To measure the pharmacokinetics (how the body treat drugs) of paracetamol and ibuprofen that are administered intravenously and determine the relative bioavailability of the tablets combination versus that of the intravenous solution

Interventions

Each participant will be randomly allocated to receive a single dose of each of the following five treatments in a balanced five-way crossover sequence: Treatment A: Intravenous administration of paracetamol 1000 mg + ibuprofen 300 mg/100mL infusion - as a 15 minutes infusion Treatment B: Intravenous paracetamol 1000 mg/100mL infusion - as a15 minutes infusion Treatment C: Intravenous ibuprofen 300 mg/100mL infusion- as a15 minutes infusion Treatment D: Intravenous paracetamol 500 mg + ibuprofen 150 mg/100 ml infusion - as 15 minutes infusion Treatment E: Two tablets of a fixed dose combination product containing paracetamol 500 mg + ibuprofen 150 mg/tablet -oral administration with a full glass of water Washout period between treatments - 7 days Dose frequency - single dose All participants complete all five periods (treatments A-E) in a cross-over fashion.

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

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 lab tests.

Outcome results