HealthyPhase 4ClonazepamNCT06834503
Bioequivalence Study of Clonazepam 2 Mg Tablets
A Phase 4 study testing Rivotril® and Clonazepam TQ 2 mg in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Donors
- What is being tested?
- Rivotril® and Clonazepam TQ 2 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 1 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
To establish the main pharmacokinetic variables of the two formulations.
- Conditions
- Healthy, Healthy Donors
- Being tested
- Rivotril®, Clonazepam TQ 2 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivotril®Drug
Rivotril® 2 mg
Clonazepam TQ 2 mgDrug
Test
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Active comparator | Rivotril® 2 mg Receives: Drug: Rivotril® |
| Period 2 | Active comparator | Clonazepam TQ 2 mg Receives: Drug: Clonazepam TQ 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Measured: 0 - 72 Hours
Pharmacokinetic Outcome Measures
The plasma concentration max
Measured: 0 - 6 Hours
Secondary outcomes (1)
Pharmacokinetic Outcome Measures
tmax .
Measured: 0 - 6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start10 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atencion e Investigacion Medica
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Humberto Reynales MD MSc PhD, Centro de Atencion e Investigacion Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834503
- Sponsor's protocol ID
- CLONAZ-BIO-002-2023
- Acronym
- Clonazepam
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Clonazepam 2 Mg Tablets/immediate Release Tablets in Healthy Subjects in a Fasting Condition
- ClinicalTrials.gov ID
- NCT06834503
- Acronym / sponsor ID
- Clonazepam / CLONAZ-BIO-002-2023
- Conditions
- Healthy, Healthy Donors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centro de Atencion e Investigacion MedicaResearch network
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To establish the main pharmacokinetic variables of the two formulations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Active comparator | Drug: Rivotril®Rivotril® 2 mg |
| Period 2 | Active comparator | Drug: Clonazepam TQ 2 mgClonazepam TQ 2 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivotril®Rivotril® 2 mg | Drug | Period 1 |
| Clonazepam TQ 2 mgTest | Drug | Period 2 |
Primary outcome
Pharmacokinetic Outcome Measures
Time frame: 0 - 72 Hours
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic Outcome Measures
Time frame: 0 - 6 Hours
The plasma concentration max
1 secondary outcome
Pharmacokinetic Outcome Measures
Time frame: 0 - 6 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivotril® and Clonazepam TQ 2 mg in people with Healthy and Healthy Donors, run by Centro de Atencion e Investigacion Medica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauricio - Vargas, Ms (+57 3138590569, mauricio.vargas@caimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Outcome Measures (time frame: 0 - 72 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.