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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777685
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):
Damanhour University

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Sulpiride Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride
Study Start Date : January 2013
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
sulpiride 50 mg Drug: Sulpiride
Other Name: Dogmatil

Primary Outcome Measures :
  1. •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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777685

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Damanhour University Identifier: NCT01777685     History of Changes
Other Study ID Numbers: PPT3
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Keywords provided by Damanhour University:
Therapeutic drug monitoring
Additional relevant MeSH terms:
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Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents