A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations

A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Paracetamol; Drug: Paracetamol formulation 1; Drug: Paracetamol Formulation 2; Drug: Paracetamol formulation 3; Drug: Paracetamol formulation 4

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • MDS Pharma Services ARIZONA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Age:Aged 18 to 50 years inclusive.
• Body Mass Index (BMI):Body Mass Index must be in the range 19 - 28 kg/m2.
• Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
• General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
• Contraception:Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion Criteria:

• Pregnancy:Women who are pregnant or who have a positive serum pregnancy test.
• Breast-feeding:Women who are breast-feeding.
• Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Clinical Study/Experimental Medication:a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study.
• Substance abuse:Recent history (within the last 5 years) of alcohol or other substance abuse.
• Personnel:An employee of the sponsor or the study site or members of their immediate family.
• Disease: a) Current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure). b) Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
• Vegetarians:Subjects who are vegetarian.
• Hepatitis and HIV Screening:Positive screening for Serum Hepatitis B Surface Antigen, Hepatitis C or Human Immunodeficiency Virus (HIV).
• Medications:Current (within 14 days of screening) or regular use of any prescription, OTC, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing, (e.g. barbiturates, theophylline, cimetidine, or erythromycin).
• Smoking:Non-smokers of less than 3 months or current use of nicotine-containing products.
• Blood:Subject has donated or experienced significant blood loss within 56 days of Visit 2, donated plasma within 7 days of Visit 2, or has a hemoglobin value of = 12.0 g/dL.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard paracetamol; Marketed formulation	Drug: Paracetamol; Paracetamol
Experimental: Formulation 1; Paracetamol formulation 1	Drug: Paracetamol formulation 1; Paracetamol
Experimental: Formulation 2; Paracetamol formulation 2	Drug: Paracetamol Formulation 2; Paracetamol
Experimental: Formulation 3; Paracetamol formulation 3	Drug: Paracetamol formulation 3; Paracetamol
Experimental: Formulation 4; Paracetamol formulation 4	Drug: Paracetamol formulation 4; paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.	Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.

Secondary Outcome Measures

Outcome Measure	Time Frame
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.	Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Analgesia; Paracetamol; otc
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: A2750596