Comparative bioavailability of diclofenac epolamine tablets vs. Flector® granules for oral solution in healthy volunteers, pilot study in fed conditions

Not Applicable

Completed

• Conditions: Diclofenac epolamine (DHEP) 50 mg soluble tablets containing 65 mg of diclofenac epolamine corresponding to 50 mg of diclofenac sodium; Not Applicable

• Registration Number: ISRCTN50053717
• Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-10
• Last Update Posted: 27 November 2017

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified