Bioequivalence Study of Clonazepam 2 Mg Tablets

NCT06834503 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CLONAZ-BIO-002-2023
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy; Healthy Donors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacokinetic Outcome Measures

  0 - 6 Hours

Study Arms (2)

Period 1

ACTIVE COMPARATOR

Rivotril® 2 mg

Drug: Rivotril®

Period 2

ACTIVE COMPARATOR

Clonazepam TQ 2 mg

Drug: Clonazepam TQ 2 mg

Interventions

Rivotril® DRUG

Rivotril® 2 mg

Period 1

Clonazepam TQ 2 mg DRUG

Test

Period 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atencion e Investigacion Medica: lead

MeSH Terms

Interventions

Clonazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Mauricio - Vargas, Ms

CONTACT

+57 3138590569; mauricio.vargas@caimed.com

Constanza N Morales, MD

CONTACT

57(601) 8707070; comite.epidemiologia@caimed.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 19, 2025
• Study Start: June 10, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Nov 2025 Dic 2030
• Access Criteria: Indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed