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

NCT01568749 | Completed Phase 1

• 1 other identifier: A2750596
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia

Keywords

otc; Analgesia; Paracetamol

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (5)

Standard paracetamol

ACTIVE COMPARATOR

Marketed formulation

Drug: Paracetamol

Formulation 1

EXPERIMENTAL

Paracetamol formulation 1

Drug: Paracetamol formulation 1

Formulation 2

EXPERIMENTAL

Paracetamol formulation 2

Drug: Paracetamol Formulation 2

Formulation 3

EXPERIMENTAL

Paracetamol formulation 3

Drug: Paracetamol formulation 3

Formulation 4

EXPERIMENTAL

Paracetamol formulation 4

Drug: Paracetamol formulation 4

Interventions

Paracetamol DRUG

Paracetamol

Standard paracetamol

Paracetamol formulation 1 DRUG

Paracetamol

Formulation 1

Paracetamol Formulation 2 DRUG

Paracetamol

Formulation 2

Paracetamol formulation 3 DRUG

Paracetamol

Formulation 3

Paracetamol formulation 4 DRUG

paracetamol

Formulation 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

MDS Pharma Services ARIZONA

Phoenix, Arizona, 85044, United States

Location

MeSH Terms

Conditions

Agnosia; Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: April 2, 2012
• Study Start: December 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 24, 2014

Record last verified: 2014-06

Locations

US (1)