Bioavailability of Clotiazepam 5 mg With Regards to Reference Product

June 17, 2020 updated by: Laboratorios Andromaco S.A.

Bioavailability of a Formulation of Clotiazepam 5 mg Coated Tablets With Regards to the Marketed Reference Product

This Pivotal study will investigate the bioavailability in fasting women of 1 Tablet formulations containing Clotiazepam 5 mg.

The Pivotal study will be performed at a single site with 30 subjects. Participants will take 1 Tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

The primary objective of the study is to investigate the relative bioavailability of

Clotiazepam of 1 tablet formulation with Clotiazepam 5 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

  • Test Product: Product manufactured by Tecnandina S.A., Ecuador.
  • Reference Product: Rize [Trademark], product of Mitsubishi Tanabe Pharma, Japan.

The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters área under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined.

Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 12 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 18 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 24 h and 34 h postdose.

The washout period between the two study periods will be at least 7 days. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel and Ethinyl estradiol in plasma.

The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.

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 (Actual)

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.
26

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 1

Contacts and Locations

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

Study Locations

  • Chile
      • Santiago, Chile, 7510491
        • Innolab

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

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-pregnant and non-breastfeeding women
  • Women of childbearing age with an acceptable form of contraception during the study
  • 18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or equal to 29.99
  • With results of laboratory tests, electrocardiogram and chest radiography in normal and / or negative or abnormal ranges but without clinical relevance and declared suitable for study by the doctor after the physical examination
  • Capable to understand the Informed Consent Form

Exclusion Criteria:

  • Study Site staff or family members
  • With history of drug and/or alcohol abuse
  • Smokers more tan 3 cigarettes every 7 days
  • Vitamin supplements intake 7 days prior to the administration of the medications under study
  • Any recent change in eating habits or physical exercise
  • Using of pharmacological therapy (except over the counter medication use 7 days prior the study)
  • Hypersensitivity to the study drug or other related compounds, history of serious adverse reactions or hypersensitivity to any medication
  • Use, during 28 days prior to the start of the study, of medications known to alter liver enzyme activity
  • Consumption of beverages or food containing grapefruit or pink grapefruit, within 7 days prior to each administration of the study medication and consumption of alcohol, caffeine or beverages or food containing xanthine 24 hours prior each administration of study medication until the last sample of each period
  • History of any significant cardiovascular disease
  • Acute disease that generates significant physiological changes from the start of the selection until the end of the study
  • HIV, Hepatitis B and/or C positive
  • Presence or history of thrombophlebitis, thrombosis or thromboembolic disorder, deep vein thrombosis, pulmonary embolism or known coagulopathy.
  • Donation or loss of a significant volume (more tan 100 mL) of blood or plasma or platelets during the 3 months prior to the start of the study
  • Subjects who have participated in any type of clinical study during the 3 months prior to the start of the study
  • History of any gastrointestinal surgery that could affect drug absorption
  • Presence of fainting history or fear to blood collection

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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.
Experimental: Clotiazepam Test Product
Drug: Clotiazepam 5 mg Test Product Coated Tablets
Investigational Medicinal Product
Active Comparator: Clotiazepam Reference Product
Drug: Clotiazepam 5 mg Reference Product Coated Tablets
Rize (Trademark)

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
Total Clotiazepam: area under the plasma concentration-time curve from 0 to 34 hours (AUC0-34).
Time Frame: From intake and up to 34 hours after tablet intake.
21 samples up to 34 hours will be taken after the administration in each period.
From intake and up to 34 hours after tablet intake.
Total Clotiazepam: area under the plasma concentration-time curve from 0 to time t (AUC0-t).
Time Frame: From intake and up to 34 hours after tablet intake.
21 samples up to 34 hours will be taken after the administration in each period.
From intake and up to 34 hours after tablet intake.
Total Clotiazepam: Maximum plasma concentration (Cmax)
Time Frame: From intake and up to 34 hours after tablet intake.
21 samples up to 34 hours will be taken after the administration in each period. The Cmax will be calculated.
From intake and up to 34 hours after tablet intake.

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
Total Clotiazepam: Time to achieve maximum plasma concentration (tmax)
Time Frame: From intake and up to 34 hours after tablet intake.
21 samples up to 34 hours will be taken after the administration in each period. The tmax will be calculated.
From intake and up to 34 hours after tablet intake.

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.
Laboratorios Andromaco S.A.

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 (Actual)

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.
March 11, 2020

Primary Completion (Actual)

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.
March 28, 2020

Study Completion (Actual)

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.
March 28, 2020

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).
June 17, 2020

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.
June 17, 2020

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.
June 19, 2020

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.
June 19, 2020

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.
June 17, 2020

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.
June 1, 2020

More Information

Terms related to this study

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.
  • HP8810-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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