A study to compare the bio-equivalence between single dose of ibuprofen tablet versus a combination of acetaminophen and ibuprofen.

Phase 1

Completed

• Conditions: Pain Relief; Anaesthesiology - Pain management

• Registration Number: ACTRN12618001465246
• Lead Sponsor: MACLEODS PHARMACEUTICALS LTD.

Brief Summary

The study confirmed that the test product (ibuprofen tablets 97.5mg manufactured by Macleods Pharmaceuticals Ltd. India) produces similar maximum blood levels and the time profile of the drugs in the body to the individual ingredient of ibuprofen in a fixed dose combination 325 (acetaminophen 325mg + ibuprofen 97.5mg). Both formulations are well tolerated following single dose administration in healthy adults under fasting conditions.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-02-21
• Study Start: 2018-08-31
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy volunteers within the age range of 18 to 45 years
Presently non-tobacco users (smokers and chewers)
Willingness to provide written informed consent to participate in the study
Body-mass index (BMI) between 18.50 kg/m2 and 29.99 kg/m2 (both inclusive) with body weight not less than 50 kg (for males) and with body weight not less than 45 kg (for females)
Absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history or physical examination during the screening.
Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
Have a normal chest X-ray PA view or one with abnormality considered to be clinically insignificant.
Comprehension of the nature and purpose of the study and compliance with the requirement of the distributed ICF
Volunteer is regularly menstruating or Volunteer is in postmenopausal phase for at least 1 year or is surgically sterile (for females).
Volunteer of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) such as condoms, foams, jellies, diaphragm, and intrauterine device (IUD) or abstinence etc. except hormonal contraceptives (for females).

Exclusion Criteria

Personal history of allergy or hypersensitivity to Ibuprofen or Acetominophen or allied drugs
Any major illness in the past 90 days or any clinically significant ongoing chronic medical illness e.g. Congestive Cardiac Failure (Heart failure), Hepatitis, Hypotensive episodes, Hyperglycemia etc.
Presence of any clinically significant abnormal laboratory values during screening e.g. Significant abnormality of liver function test, renal (kidney) function test etc
Severe cardiac, renal or liver impairment, gastro-intestinal disease or other conditions, any other organ or system impairment.
History of seizures, epilepsy or any kind of Neurological disorders
Past history of Anaphylaxis or Angioedema
Presence of disease markers of HIV or Hepatitis B or Hepatitis C virus.
History of chronic consumption of any kind of alcoholic beverages for more than 2 years or having consumed alcohol within 48 hours prior to dosing.
Consumption of products containing xanthine derivatives (chocolates, tea, coffee or cola drinks) or tobacco products within 48 hours prior to dosing.
Consumption of grapefruit or grapefruit containing products or any cruciferous vegetables (eg. broccoli, brussels sprouts, etc.) or char-broiled meat prior 7 days of investigational product administration.
Use of any recreational drug or a history of drug addiction
Participation in any clinical trial within the past 90 days.
History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
Donation of blood (one unit or 350 mL) within 90 days prior to receiving the first dose of study medication
Consumption of any other prescription drug or over the counter (OTC) drugs (including vitamins and medicinal products from natural origin) within two weeks prior to receiving the
first dose of study medication or repeated use of drugs within the last four weeks.
An unusual diet for whatever reason e.g. low sodium diet, for two weeks prior to receiving any medication and throughout subject's participation in the study
Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 48 hours prior to the study.
Known hypersensitivity to heparin
Use of oral contraceptive in last 90 days (for females)
Pregnant or Iactating volunteers (for females)

Study & Design

• Study Type: Interventional
• Study Design: Not specified