Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers (SUL)
This study has been completed.
Information provided by (Responsible Party):
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013
The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral administration.
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
||Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
sulpiride 50 mg
Other Name: Dogmatil
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.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01777685
|Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
|Damanhour, Egypt |
No publications provided by Damanhour University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2013
||January 28, 2013
||Egypt: Institutional Review Board
Keywords provided by Damanhour University:
Therapeutic drug monitoring
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation