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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01568749
First received: June 23, 2011
Last updated: June 19, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Analgesia
Drug: Paracetamol
Drug: Paracetamol formulation 1
Drug: Paracetamol Formulation 2
Drug: Paracetamol formulation 3
Drug: Paracetamol formulation 4
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive. [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive. [ 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. ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568749

Locations
United States, Arizona
MDS Pharma Services ARIZONA
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01568749     History of Changes
Other Study ID Numbers: A2750596
Study First Received: June 23, 2011
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
otc
Paracetamol
Analgesia

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 09, 2014