Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers (SUL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Damanhour University
ClinicalTrials.gov Identifier:
NCT01777685
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral administration.


Condition Intervention
Healthy
Drug: Sulpiride

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride

Further study details as provided by Damanhour University:

Primary Outcome Measures:
  • •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 ] [ Designated as safety issue: Yes ]
    Assessment of the pharmacokinetics using compartmental and non compartmental analysis of sulpiride after oral administration


Enrollment: 16
Study Start Date: January 2013
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sulpiride 50 mg Drug: Sulpiride
Other Name: Dogmatil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01777685

Locations
Egypt
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Damanhour, Egypt
Sponsors and Collaborators
Damanhour University
  More Information

No publications provided by Damanhour University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Damanhour University
ClinicalTrials.gov Identifier: NCT01777685     History of Changes
Other Study ID Numbers: PPT3
Study First Received: January 25, 2013
Last Updated: January 28, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Damanhour University:
Sulpiride
Therapeutic drug monitoring
Pharmacokinetics

Additional relevant MeSH terms:
Sulpiride
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014