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Clinical Trial Details

Trial ID: L4734
Source ID: NCT04170790
Associated Drug: Saxagliptin 5mg
Title: Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Erectile Dysfunction With Diabetes Mellitus|Drug Interaction
Interventions: DRUG: Saxagliptin 5mg|DRUG: Sildenafil 50 mg
Outcome Measures: Primary: Cmax, Maximum Plasma Concentration, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|(AUC0→∞), Area Under Curve Infinity, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|(AUC0→t), Area Under the Curve, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|tmax;, Time to reach Maximum concentration, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|T½, Drug half Life, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|Ke, Elimination Rate, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|ka, Absorption Rate, pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.|Blood Pressure, changes in Systolic and Diastolic Blood Pressure from normal range, measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling|Heart Rate, Changes in heart rate from normal range, measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling |
Sponsor/Collaborators: Sponsor: Ain Shams University
Gender: MALE
Age: ADULT
Phases:
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: |Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2019-12-01
Completion Date: 2020-01-30
Results First Posted:
Last Update Posted: 2019-11-20
Locations:
URL: https://clinicaltrials.gov/show/NCT04170790