A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

Completed · Phase 1

Conditions studied: Pain

In brief

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

Key facts

Study ID

NCT01551797

Run by

GlaxoSmithKline

People needed

14

Starts

2010-05-01

Expected to finish

2010-10-01

Last updated by the study team

2012-12-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

You may not qualify if…

• Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
• Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.

Where it is running

• Charles River Clinical Services Northwest, Inc. — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.