Bioequivalence Study of Clonazepam 2 Mg Tablets (Clonazepam)

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: Not yet recruiting
• Conditions: Healthy; Healthy Donors
• Intervention / Treatment: Drug: Rivotril®; Drug: Clonazepam TQ 2 mg

Detailed Description

To establish the main pharmacokinetic variables of the two formulations.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mauricio - Vargas, Ms; Phone Number: +57 3138590569; Email: mauricio.vargas@caimed.com
• Study Contact Backup: Name: Constanza N Morales, MD; Phone Number: 57(601) 8707070; Email: comite.epidemiologia@caimed.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Outcome Measures	Area under the plasma concentration versus time curve (AUC)	0 - 72 Hours
Pharmacokinetic Outcome Measures	The plasma concentration max	0 - 6 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Outcome Measures	tmax .	0 - 6 Hours

Collaborators and Investigators

• Sponsor: Centro de Atencion e Investigacion Medica

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; GABA Modulators; GABA Agents; Anticonvulsants; Clonazepam
• Other Study ID 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