Pain
Conditions
Interventions
Trade Name: Ipren, 200 mg film-coated tablet
Product Name: Ipren
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Conc
Sponsors
McNeil AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female volunteers subjects between the ages of 18 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the investigator, based on a detailed medical history, a physical examination, including blood pressure and pulse rate measurements, 12-lead electrocardiogram, as well as clinical laboratory tests. The responsible investigator may request additional investigations or analyses if necessary. 2. Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine for at least 12 months before screening visit of this study. 3. For females: Postmenopausal state (absence of menstrual discharge for at least two years and a follicle stimulating hormone (FSH) serum level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, transdermal, hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization), single male partner who has had a vasectomy, or declared absence of sexual contact, with a male partner, during the study. Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study. 4. Body Mass Index (BMI) = 18.5 and = 30.0 kg/m2. 5. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. 6. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of medications other than contraceptives or occasional use of paracetamol or NSAIDs. 2. Use of NSAIDs (or any other product containing NSAIDs) within 7 days before the first treatment visit and throughout the study. 3. History of significant allergy or hypersensivity (e.g. asthma, angioedema) to ibuprofen, ASA, other NSAIDs or any related products (including excipients of the formulations). 4. Females: Pregnancy and/or breast-feeding. 5. History of peptic ulcer or gastrointestinal bleeding. 6. Treatment with an investigational drug within 3 months preceding the first dose of study treatment. 7. Preplanned surgical procedures during the study period, if this may interfere with the conduct of the study. 8. History of regular alcohol consumption in the 6 months before screening, exceeding weekly limits of 2 L of wine or 5 L of beer or 0.6 L of spirits for females, and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages. 9. Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL. 10. Relationship to persons involved directly in the conduct of the study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the sponsor or Johnson & Johnson subsidiaries, and the family of each).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show bioequivalence between Ipren film coated tablet 200 mg and Brufen film coated tablet 200 mg, with respect to the single-dose pharmacokinetics of S-(+) ibuprofen. The maximum observed plasma concentrations (Cmax), and the areas under the concentration-vs.-time curve until last measurable concentration (AUCt), will be compared to assess bioequivalence.;Secondary Objective: • to compare the area under the concentration-vs.-time curve extrapolated to infinity (AUC8) of S-(+) ibuprofen, between treatments, • to compare Cmax, AUCt and AUC8 of R-(-) and total ibuprofen, respectively, between treatments, • to further describe the pharmacokinetics of R-(-), S-(+) and total ibuprofen, respectively, of the investigational products with respect to: o the time at which the maximum concentration is observed (tmax), o the terminal elimination rate constant (?z), o the terminal half-life (t1/2), o the mean residence time (MRT), o the extrapolated part of AUC8 (AUCExtra) • to evaluate the tolerability of the investigational products based on reported and observed Adverse Events (AEs). ;Primary end point(s): The primary study endpoints are the Cmax and AUCt of S-(+) ibuprofen.;Timepoint(s) of evaluation of this end point: Pre-dose and at 15, 30, 40, 50, 60, 70, 80, 90, and 105 minutes as well as at 2, 2.5, 3, 4, 5, 6, 7, 9, and 12 hours after study drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study endpoints are: • Cmax and AUCt of R-(-) and total ibuprofen, respectively, • AUC8, tmax, ?z, t1/2, AUCExtra and MRT of R-(-), S-(+) and total ibuprofen, respectively, • the occurrence of Adverse Events (AEs). ;Timepoint(s) of evaluation of this end point: Pre-dose and at 15, 30, 40, 50, 60, 70, 80, 90, and 105 minutes as well as at 2, 2.5, 3, 4, 5, 6, 7, 9, and 12 hours after study drug administration. | — |
Countries
Sweden
Contacts
Public ContactIngrid Ademar
McNeil AB
Outcome results
None listed