This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
SeaView Research, Inc.
Miami, Florida, United States
Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
Pharmacokinetic Assessment of CVC, as measured by minimum plasma concentration (Cmin)
Time frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
Pharmacokinetic Assessment of CVC, as measured by area under the plasma concentration-time curve (AUC)
Time frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
Evaluation of Adverse Events
Evaluate adverse events
Time frame: 23 days
Changes from Baseline in Clinical Laboratory Tests
Evaluate changes from baseline in clinical laboratory tests including serum chemistry, hematology and urinalysis
Time frame: Baseline and 23 days
Changes from Baseline in 12-lead ECGs
Evaluate changes from baseline in 12-lead ECGs
Time frame: Baseline and 23 days
Changes from Baseline in Vital Signs
Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
Time frame: Baseline and 23 days
Changes from Baseline in Physical Examinations
Evaluate changes from baseline in physical examinations
Time frame: Baseline and 23 days
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