Single dose 150mg APO-Dabigatran given with 24 hours of Pharmacokinetic (PK) testing post dose

4-7 doses of rabeprazole followed by single dose 150mg APO-Dabigatran given with 24 hours of Pharmacokinetic (PK) testing post dose

Atrial Fibrillation

Venous Thromboembolism

Absorption of APO-Dabigatran measured with and without influence of rabeprazole

RABEprazole 20 Mg Oral Delayed Release Tablet

Absorption of APO-Dabigatran post single dose

APO-Dabigatran 150mg

Inc. A. APO-dabigatran Product Monograph.

Dabigatran etexilate hard capsule 75mg, 110mg, 150mg product-specific bioequivalence guidanc

The Population Health Research Institute

A Study on the Impact of Rabeprazole-induced Elevated Stomach pH on APO-Dabigatran Exposure in Healthy Volunteers

Impact of Rabeprazole-induced Elevated Gastric pH on APO-Dabigatran Exposure in Healthy Volunteers

As measured by area under the curve (AUC)

dilute thrombin time measured at 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours to calculate AUC and maximum

activated partial thromboplastin time measured at 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours to calculate AUC and maximum

Population Health Research Institute

Hamilton Health Sciences Corporation

Dengue Fever

Pleural Effusion

2 mg of Ketotifen, twice a day for a total of ten (10) doses

Ketotifen

Identical tablets containing 0 mg of Ketotifen, twice a day for a total of ten (10) doses

Placebo

National University Hospital (Investigational Medicine Unit)

Singapore General Hospital

Ketotifen as a Treatment for Vascular Leakage During Dengue Fever

Ketotifen as a Treatment for Vascular Leakage During Dengue Fever (KETODEN)

fluid accumulation in the pleural cavity will be measured by MRI

Serum biomarker for mast cell activation, chymase, will be measured in serum

hemoconcentration will be measured by hematocrit

This is determined by the presence of rash, petechiae, purpura, ecchymoses, epistaxis, or other signs of bleeding, pain, or discomfort

Factors taken into account include: RNA expression levels, plasma chymase levels, viral load, hematology (full blood count), viral protein levels, inflammatory cytokines, inflammatory lipids (such as eicosanoids), and expression of activation markers, and genetic factors

fumaric acid/hemorrhage

A Study on the Impact of Rabeprazole-induced Elevated Stomach pH on APO-Dabigatran Exposure in Healthy Volunteers

Ketotifen as a Treatment for Vascular Leakage During Dengue Fever

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