- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101370
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
September 23, 2019 updated by: Geropharm
Two-way Crossover, Open-label, Single-dose, Bioequivalence Study of Bosentan (LLC "GEROPHARM", Russia) 125 mg Tablets Immediate Release (IR )Versus Tracleer® (Actelion Pharmaceuticals Ltd., Switzerland) 125 mg Tablets IR in Normal Healthy Subjects Under Fasting Conditions
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers.
Tracleer® Actelion)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study to evaluate the bioequivalence of orally administered bosentan preparations, immediate release tablets, 125 mg in normal healthy subjects under fasting conditions
Study Type
Interventional
Enrollment (Actual)
64
Phase
- 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
-
-
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Yaroslavl, Russian Federation, 150007
- Clinical Hospital № 3
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-
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
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Signed informed consent form.
- Healthy male aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 30 kg/m2.
- Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.
- Ability to keep fasting state for at least 14 hours.
- Consent and ability to respect the schedule of visits and the points of the Protocol.
Exclusion Criteria:
- History of serious allergic problems/events.
- Medicinal intolerance.
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Psychiatric disorders, history of epilepsy and seizures.
- Acute infectious diseases in less than 4 weeks before the start of the study.
- Subjects who have taken medication 2 weeks preceding before the study.
- Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
- Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
- History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- Smokers.
- Participation in other clinical training is less than than for 3 months before the study.
- Lack of signed informed consent form.
- 10% deviation from references in lab tests.
- Positive testing for alcohol, drugs.
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
- Any diet (vegetarian, etc.) extreme physical exercise, night shift work.
- Heart rate below 60 or above 80 beats per minute.
- Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
- Diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.
- Volunteers, for Investigator opinion, who can not understand and evaluate the information about this study.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bosentan
Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition
|
Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition
Other Names:
|
Active Comparator: Tracleer®
Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition
|
Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
|
Pharmacokinetics of bosentan by Assessment of Observed Maximum Plasma Concentration (Cmax)
|
0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
|
AUC(0-t)
Time Frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
|
Pharmacokinetics of bosentan by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
|
0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 24, 2018
Primary Completion (Actual)
June 20, 2018
Study Completion (Actual)
June 20, 2018
Study Registration Dates
First Submitted
September 23, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (Actual)
September 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 23, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOZ-501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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