Drug-Drug Interaction Study of Voriconazole With Clarithromycin.

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: Male

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 oral dose, open-label, crossover, and randomized trial. In the first phase of the study, the principal investigator developed a high-performance-liquid chromatography (HPLC) method and validation according to standard ICH guidelines for the quantification of voriconazole in the biological matrix. During the second step, Enrolled volunteers were divided randomly into group A and group B by the "permuted block randomization" technique. Then, voriconazole either alone (2 x 200mg, tab, P/O) or in combination with clarithromycin (Voriconazole 2 x 200mg, tab + clarithromycin 500mg, tab, P/O) was administered to enrolled volunteers in two sequences. Finally, sample collection was carried out and blood samples were collected at specified time periods (i.e., 0.0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, and 24 hours) in EDTA or heparinized tubes from the enrolled human volunteers. Further processing of the sample was done for extractions and subsequent analysis with the developed analytical method.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abdul Wali Khan University Mardan
• Treatments: Clarithromycin; Voriconazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.