To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
Condition: Healthy
Intervention: Ibuprofen; Caffeine; Ibuprofen
Intervention MeSH terms: Ibuprofen; Caffeine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg
      caffeine against 400 mg ibuprofen alone under fed conditions
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy males and females, 18 to 50 years (inclusive) at time of screening.

          -  Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).

          -  Body mass not less than 50 kg.

          -  Medical history, vital signs, physical examination, standard 12-lead electrocardiogram
             (ECG) and laboratory investigations must be clinically acceptable or within laboratory
             reference ranges for the relevant laboratory tests, unless the PI considers the
             deviation to be irrelevant for the purpose of the study.

          -  Non-smokers and mild or moderate smokers (<= 10 cigarettes or pipes per day). Further
             inclusion criteria apply

        Exclusion criteria:

          -  Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional
             or intellectual problems likely to limit the validity of consent to participate in the
             study or limit the ability to comply with protocol requirements.

          -  Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol
             per week for females. One unit is equal to beer [200 mL/10 ounces], wine [100 mL/4
             ounces], or distilled spirits [25 mL/1 ounce]) per day

          -  Regular exposure to substances of abuse (other than alcohol) within the past year.

          -  Use of any medication, prescribed or over-the-counter or herbal remedies, within 2
             weeks before the first administration of IMP except if this will not affect the
             outcome of the study in the opinion of the PI. In this study the concomitant use of
             hormonal contraceptives is allowed.

          -  Participation in another study with an experimental drug, where the last
             administration of the previous IMP was within 8 weeks (or within 5 elimination
             half-lives for chemical entities or 2 elimination half-lives for anti-bodies or
             insulin), whichever is the longer) before administration of IMP in this study, at the
             discretion of the PI.

          -  Treatment within the previous 3 months before the first administration of IMP with any
             drug with a well-defined potential for adversely affecting a major organ or system.

          -  History of hypersensitivity or allergy (angioedema or urticaria) to the IMP or its
             excipients or any related medication (Aspirin or any other NSAID).

          -  Diagnosis of hypotension made during the screening period.

          -  Diagnosis of hypertension made during the screening period or current diagnosis of
             hypertension.

          -  Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening
             period, either supine or standing.

          -  Renal impairment.

          -  Positive urine screen for drugs of abuse. In case of a positive result the urine
             screen for drugs of abuse may be repeated once at the discretion of the PI.

        Further exclusion criteria apply