Last updated: 11/04/2018 04:20:34
A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations
Trial description: A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Timeframe: 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:
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Timeframe: Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Interventions:
Drug: Paracetamol
Drug: Paracetamol formulation 1
Drug: Paracetamol Formulation 2
Drug: Paracetamol formulation 3
Drug: Paracetamol formulation 4
Enrollment:
14
Observational study model:
Not applicable
Primary completion date:
2009-31-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Analgesia
Product
paracetamol
Collaborators
Not applicable
Study date(s)
January 2009 to August 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- 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.
- Pregnancy:Women who are pregnant or who have a positive serum pregnancy test.
- Breast-feeding:Women who are breast–feeding.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2009-31-08
Actual study completion date
2009-31-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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