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

NCT ID: NCT01777685

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-01-31

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

sulpiride 50 mg

Group Type: OTHER

Sulpiride

Intervention Type: DRUG

Interventions

Sulpiride

Intervention Type: DRUG

Other Intervention Names

Dogmatil

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pharmaceutics Department, Faculty of Pharmacy, Damanhour University

Damanhur, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 23585286 (View on PubMed)

Other Identifiers

PPT3

Identifier Type: -

Identifier Source: org_study_id