Bioequivalence of diclofenac sodium retard

Phase 1

• Conditions: Arthritis; Rheumatoid Arthritis; Arthritis, Rheumatoid; Healthy Volunteers; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Autoimmune Diseases; Rheumatic Diseases; Autoimmune System Diseases

• Registration Number: RPCEC00000254
• Lead Sponsor: Center for Pharmaceutical Research and Development, Havana, Cuba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•Written informed consent.
•Aged between 18-50 years.
•Volunteers of both sexes.
•Volunteers’ weight: +/- 15% of their ideal weight for height.
•Failure to submit evidence of organic or psychiatric disease according to interrogation, physical examination and laboratory tests.
•Not have evidence or history of diseases such as bronchial asthma, hypertension, bad-absorption syndrome, peptic ulcer or duodenal present, liver failure, kidney failure, severe allergic reactions, atopic dermatitis, cardiovascular disorders, diabetes mellitus.
•Satisfactory physical examination.
•Present vital signs values within the following reference ranges. Systolic blood pressure between 90 and 130 mm Hg and diastolic blood pressure between 60 and 80 mm Hg, heart rate between 60 to 100 beats per minute, respiratory rate between 12 to 20 breaths per minute.
•Not having consumed alcohol, drinks containing xanthines (tea, coffee, and cola) and carbonated beverages three days before the start of each period and during it.
•Smoking or non-smoking subjects. A record of cigars use will be made.
•Laboratory results within the acceptance range. For some parameters such as blood counts with differential, urine, etc., a result found outside the reference range will be carefully evaluated by the clinical investigator.
•Post-menopausal women (age 45 or older with at least two years of amenorrhea) or documented history of hysterectomy and / or oophorectomy double sex.
•Female subject within childbearing age who use a (non-hormonal) contraceptive effective method at least 14 days before the first dose of product research and continued throughout the study. The decision to use effective contraception will be conducted by the principal investigator or clinical investigator responsible of medical care.

Exclusion Criteria

•Failure to comply with any of the inclusion criteria.
•History of allergy, idiosyncratic or hypersensitivity to aspirin, other NSAIDs or the components of the formulations under study.
•Refer some viral disease in the last 7 days.
•To be ingesting some medication 15 days (or for 5 half-lives) before the first dose of product research or nonprescribed or free drugs (OTC drugs) or herbal medicines / dietary supplements in a period seven days before the first dose of research products until the end of the study.
•Total bilirubin values hihger than 1.5 times the upper limit of the reference range.
•Serum creatinin values higher than 1.5 times the upper limit of the reference range.
•Values of AST, ALT and GGT higher than 2 times the upper limit of the reference range.
•Positive for hepatitis B and C virus, HIV or serology.
•History of alcoholism in the past 6 months (not less consumption ¼ bottle of rum or one (1) bottle of wine or three (3) beers in a higher frequency of twice a week.
•Patients with a history of drug consumption dependence or drug abuse.
•Blood donation 3 months prior to baseline.
•Participation in a clinical trial in the last 6 months.
•To be undergone major surgery within 6 months prior to baseline.
•Pregnancy and / or breastfeeding.
•History or antecedents of drug allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variable<br>- Plasma levels of diclofenac sodium (values expressed in ng/mL): Measuring time: At the beginning and at 0.5; 0.75; 1; 1.33; 1.66; 2; 2.50; 3; 4; 6; 8; 10; 12 and 24 hours after oral administration.

Secondary Outcome Measures

Name	Time	Method
Clinical safety<br>Vital signs (body temperature in degrees centigrade, heart rate in beats / minute, blood pressure in mm Hg and respiration rate in breaths per minute). Measuring time: Prior to administration of the tablets, during the first 4 hours after administration, and at the end of each period.<br>Biological safety<br>Hematology and clinical biochemistry determinations (numerical values as units of measurement for each determination). Measuring time: At the beginning and end of the study.