Bioequivalence Study of Clonazepam 2 Mg Tablets (Clonazepam)

March 5, 2025 updated by: Humberto Reynales MD MSc PhD, Centro de Atencion e Investigacion Medica

Bioequivalence Study of Clonazepam 2 Mg Tablets/immediate Release Tablets in Healthy Subjects in a Fasting Condition

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To establish the main pharmacokinetic variables of the two formulations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.
  • Subjects with the clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical selection. Current for 3 months.
  • Subjects non-smokers for the last 3 months at the time of signing the informed consent.
  • Having signed the informed consent for the study.
  • Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.
  • Body mass index between 18-30 kg/m2 at the time of inclusion in the study.
  • Subject with complete contact information (cell phone and/or landline contact, address).
  • Subject with a family member or guardian with a contact telephone number.
  • Subject with the availability of time to comply with the scheduled visits and activities.
  • Subject willing to comply with the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • 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.
  • Pregnant or breastfeeding women (Table 2).
  • Xanthine consumption from coffee, tea or chocolate during the 48 hours prior to hospitalization.
  • Alcohol consumption of more than 16 g per week equivalent to 1 beer or 2 glasses of wine during the 5 days prior to administration of the investigational product.
  • Positive test for consumption of drugs of abuse or psychoactive substances at the time of screening or prior to administration of the investigational product. (Table 2)
  • Known hypersensitivity to the active substance or excipients of the test product.
  • Medical history of angioedema or anaphylaxis.
  • Subject diagnosed with human immunodeficiency virus, hepatitis B (surface antigen) or hepatitis C (surface antigen) positive infection.
  • Having participated in clinical trials in the 4 months prior to the time of signing the informed consent.
  • Have donated blood or reported blood loss greater than 500 mL in the 30 days prior to the time of investigational product administration.
  • Subject with clinically significant acute illness or temperature > 38°C within 24 hours prior to administration of the investigational product.
  • Subject with any contraindication to blood collection due to bleeding disorders or thrombocytopenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Period 1
Rivotril® 2 mg
Drug: Rivotril®
Rivotril® 2 mg
Active Comparator: Period 2
Clonazepam TQ 2 mg
Drug: Clonazepam TQ 2 mg
Test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Outcome Measures
Time Frame: 0 - 72 Hours
Area under the plasma concentration versus time curve (AUC)
0 - 72 Hours
Pharmacokinetic Outcome Measures
Time Frame: 0 - 6 Hours
The plasma concentration max
0 - 6 Hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Outcome Measures
Time Frame: 0 - 6 Hours
tmax .
0 - 6 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro de Atencion e Investigacion Medica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLONAZ-BIO-002-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

Nov 2025 Dic 2030

IPD Sharing Access Criteria

Indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings