Status:
COMPLETED
Drug-Drug Interaction Study of Voriconazole With Clarithromycin.
Lead Sponsor:
Abdul Wali Khan University Mardan
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
PHASE4
Brief Summary
The current study evaluated the Pharmacokinetic (PK) drug-drug interaction (PK-DDI) of voriconazole with clarithromycin in healthy male volunteers. The drug interaction study was designed as a single ...
Detailed Description
Study Design and Ethical Approval: The drug interaction study was designed as a single oral dose, open-label, randomized, cross-over study of healthy volunteers. The ethical approval of the protocol w...
Eligibility Criteria
Inclusion
- • Male Pakistani volunteers in good health aged 18-35 years were enrolled as participants in this study.
- The selection was based on:
- A complete detailed medical history,
- Clinical examination,
- Voriconazole hypersensitivity test,
- Evaluation of various biochemical tests like Blood Glucose Level, Hemoglobin (Hb) Level, Serum Glutamic-Pyruvic Transaminase (SGPT) Or Alanine Amino Transferase and Aspartate (ALT and AST, respectively) Level, Urine Test, Albumin to Creatinine Ratio (ACR) Test, Glomerular Filtration Rate (GFR) Level, etc.
Exclusion
- Those volunteers were having a history of voriconazole hypersensitivity reaction were excluded from the study.
- Deviation from normal values in the biochemical test report was excluded from the study.
- Having any pathology like chronic renal disease, and hepatic impairment was excluded from the study.
- Having any cardiovascular, gastrointestinal tract, and hematopoietic disorders were excluded from the study.
- Alcohol addicted, smokers and volunteers who cannot sign the permission consent form were excluded from the study.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05380245
Start Date
November 1 2018
End Date
November 30 2018
Last Update
May 18 2022
Active Locations (1)
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1
Medical Dispensary, Abdul Wali Khan University Mardan, Pakistan.
Mardan, KPK, Pakistan, 25000