Diclofenac epolamine (DHEP) 50 mg soluble tablets containing 65 mg of diclofenac epolamine corresponding to 50 mg of diclofenac sodium Not Applicable
Conditions
Interventions
Test product (T): Diclofenac epolamine (DHEP) 50 mg soluble tablets containing 65 mg of diclofenac epolamine corresponding to 50 mg of diclofenac sodium
Reference therapy (R): Flector® granules for or
Sponsors
IBSA Institut Biochimique SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: males, 18-55 year old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-leads, supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate (Cmax) and extent (AUC0-t) of absorption of diclofenamic acid: the concentration of diclofenamic free acid in plasma was measured at the following time-points: pre-dose (0) and 3, 9, 15, 21, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6 and 8 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic (PK) profile of diclofenamic acid: the concentration of diclofenamic free acid in plasma was measured at the following time-points: pre-dose (0) and 3, 9, 15, 21, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6 and 8 h post-dose 2. Safety and tolerability of diclofenamic acid: 2.1. Record of adverse events: AEs assessed throughout the study 2.2. Vital signs: subjects' blood pressure (BP) and heart rate (HR) measured by the investigator or his/her deputy after 5 min at rest in sitting position at: screening visit, day 1 of each period: pre-dose (0) and 8 h post-dose, ETV. The check on day 1, 8 h post-dose of period 2, also corresponded to the final assessment 2.3. Electrocardiograms: a 12-lead resting ECG performed and interpreted by the investigator at the screening and final visit 2.4. Physical examination, performed at screening and at final visit. Body weight (BW) recorded at screening and at final visit. Subjects weighed (kg) lightly clothed without shoes 2.5. Height and Body Mass Index (BMI) recorded at screening visit. BMI calculated as weight [kg] / (height [m] squared) 2.6. Laboratory analysis: routine haematology, blood chemistry and urinalysis laboratory tests performed under fasting conditions at screening 2.7. A urine drug test performed using a urine multi-drug kit at screening. The following drugs assessed: cocaine, amphetamine, methamphetamine, cannabinoids (delta-9-tetrahydrocannabinol - THC), opiates and ecstasy. The same analyses, with the exception of drug screening and virology, performed at the final visit | — |
Countries
Switzerland
Outcome results
None listed