Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Pharmacokinetic variable
- Plasma levels of digoxin (values expressed in ng/mL): Measuring time: At the beginning and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours after administration.
Key secondary outcomes:
- Presence of adverse events (AE)
- distribution frequency for the appearance of adverse events (Yes, No),
- type of event (name of the AE),
- duration (time from appearance to end of the event),
- severity (severe, non-severe),
- intensity of AE (grades 1-5),
- relation of causality (remote, possible, probable, very probable),
- result of AE (recuperate, improvement, persist or sequels),
- attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: At each administration and during the whole study.
Clinical laboratory tests:
- Hematology (hemoglobin, hematocrit, erythrocytes count, white blood cells counts, platelet count) and
- Biochemistry (glycemia, cholesterol, triglycerides, transaminases, alkaline phosphatase, urea, creatinine, total proteins, total bilirubin) determinations (numerical values as units of measurement for each determination).
Measuring time: At the beginning and end of the study.
- Vital signs (body temperature in degrees centigrade, heart rate in beats / minute, blood pressure in mm Hg and respiration rate in breaths per minute). Measuring time: Prior to administration of the tablets, during the first 4 hours after administration, and at the end of each period.