- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01777685
Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers (SUL)
January 28, 2013 updated by: Damanhour University
Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride
The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral administration.
Study Overview
Detailed Description
The present study was adopted to evaluate the pharmacokinetics of sulpiride after administration of single oral doses of 50 mg in an open-label, one-way study.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
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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Damanhour, Egypt
- Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
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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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- At least 18 years old and not more than 45 healthy male volunteers
- Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
- Who had passed all the screening parameters
- Free of any drug exposure known to interfere with the pharmacokinetics or assay of sulpiride for at least 10 days prior to the study
- Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
Exclusion Criteria:
- A clinically significant abnormal physical exam, medical history, or laboratory studies If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening A history of serious intolerance, allergy, or sensitivity to fexofenadine The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days A history of blood dyscrasias A history of alcohol or drug abuse within the past year Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study Unable to tolerate vein puncture and multiple blood samplings Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion Cannot follow instructions, in the opinion of the investigator.
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: sulpiride 50 mg
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
•Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference. Pharmacokinetics of sulpiride
Time Frame: The pharmacokinetic analysis is done after blood sampling
|
Assessment of the pharmacokinetics using compartmental and non compartmental analysis of sulpiride after oral administration
|
The pharmacokinetic analysis is done after blood sampling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2013
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
January 25, 2013
First Submitted That Met QC Criteria
January 28, 2013
First Posted (Estimate)
January 29, 2013
Study Record Updates
Last Update Posted (Estimate)
January 29, 2013
Last Update Submitted That Met QC Criteria
January 28, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Dopamine Agents
- Dopamine Antagonists
- Antidepressive Agents, Second-Generation
- Sulpiride
Other Study ID Numbers
- PPT3
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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