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

NCT01777685 | Completed DMC

• 1 other identifier: PPT3
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Sulpiride; Therapeutic drug monitoring; Pharmacokinetics

Outcome Measures

Primary Outcomes (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

  Assessment of the pharmacokinetics using compartmental and non compartmental analysis of sulpiride after oral administration

  The pharmacokinetic analysis is done after blood sampling

Study Arms (1)

sulpiride 50 mg

OTHER

Drug: Sulpiride

Interventions

Sulpiride DRUG

Also known as: Dogmatil

sulpiride 50 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Pharmaceutics Department, Faculty of Pharmacy, Damanhour University

Damanhur, Egypt

Location

Related Publications (1)

• Helmy SA. Therapeutic drug monitoring and pharmacokinetic compartmental analysis of sulpiride double-peak absorption profile after oral administration to human volunteers. Biopharm Drug Dispos. 2013 Jul;34(5):288-301. doi: 10.1002/bdd.1843. Epub 2013 May 19.

  PMID: 23585286 DERIVED

MeSH Terms

Interventions

Sulpiride

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

EG (1)