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Bioequivalence Study of Clonazepam 2 Mg Tablets

ConditionsHealthyHealthy Donors
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Rivotril®

    Drug

    Rivotril® 2 mg

  • Clonazepam TQ 2 mg

    Drug

    Test

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Period 1Active comparator 1 intervention
Group B: Period 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetic Outcome Measures

Area under the plasma concentration versus time curve (AUC)

Time frame
0 - 72 Hours
2

Pharmacokinetic Outcome Measures

The plasma concentration max

Time frame
0 - 6 Hours

Secondary outcomes

1

Pharmacokinetic Outcome Measures

tmax .

Time frame
0 - 6 Hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro de Atencion e Investigacion Medica

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: