RPCEC00000265Not yet recruitingPhase 1

Bioequivalence study of a formulation of Trienor in healthy volunteers

Center for Pharmaceutical Research and Development, Havana, Cuba.0 sites72 target enrollmentStarted: January 30, 2018Last updated: August 19, 2024

Conditions

Trial Snapshot

No summary available.

Study Type: Interventional
Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Crossover. Purpose: Other

•1- Written informed consent.
•2- Aged between 18-50 years.
•3- Male subjects.
•4- Volunteers’ weight: +/- 15% of their ideal weight for height.
•5- Failure to submit evidence of organic or psychiatric disease according to interrogation, physical examination and laboratory tests.
•6- 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.
•7- Satisfactory physical examination.
•8- 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.
•9- 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.
•10- Smoking or non-smoking subjects. A record of cigars use will be made.
•11- 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.

•1- Failure to comply with any of the inclusion criteria.
•2- History of allergy, idiosyncratic or hypersensitivity to levonorgestrel or etinilestradiol or the components of the formulations under study.
•3- Refer some viral disease in the last 7 days.
•4- 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.
•5- Total bilirubin values hihger than 1.5 times the upper limit of the reference range.
•6- Serum creatinin values higher than 1.5 times the upper limit of the reference range.
•7- Values of AST, ALT and GGT higher than 2 times the upper limit of the reference range.
•8- Positive for hepatitis B and C virus, HIV or serology.
•9- 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.
•10- Patients with a history of drug consumption dependence or drug abuse.
•11- Blood donation 3 months prior to baseline.
•12- Participation in a clinical trial in the last 6 months.
•13- To be undergone major surgery within 6 months prior to baseline.
•14- History or antecedents of drug allergy.

Sponsor

Center for Pharmaceutical Research and Development, Havana, Cuba.