Bioequivalence Study of Clonazepam 2 Mg Tablets
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCentro de Atencion e Investigacion Medica
About this trial
Demonstrate the bioequivalence in 1 study, in fasting condition of two formulations of clonazepam 2 mg Tablets / tablets immediate release in order to establish that there are no significant pharmacokinetic differences.
Eligibility criteria
Qualifiers
Women and men between 18 and 50 years of age at the time of signing the informed consent form.
Women who are not capable of conceiving (To be considered not capable of conceiving she must be at least 1 year postmenopausal or surgically sterile) or who are not pregnant or breastfeeding.
Women of childbearing capacity must be using adequate contraception for the past 6 months and agree to continue using adequate contraception for 30 days after signing the consent form.
Have been clinically diagnosed as healthy by the study physician.
Disqualifiers
Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease, compulsive depressive disorder.
Subject with diagnosis of hematological disorders, such as anemias and/or polycythemia.
Subjects with history of gastric surgeries.
Permanent or temporary use during the last 5 days prior to the administration of the investigational product of the study of any type of medication either on their own initiative or by medical prescription. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of the present study.
Trial design
Treatments tested in this trial
- Rivotril®
- Clonazepam TQ 2 mg
Treatment groups
24 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov