Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Pharmacokinetics - Cmax (Doxylamine) |
Maximum plasma concentration (Cmax) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - Cmax (Pyridoxal-5-phosphate) |
Maximum plasma concentration (Cmax) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - tmax (Doxylamine) |
Time to reach Cmax (tmax) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - tmax (Pyridoxal-5-phosphate) |
Time to reach Cmax (tmax) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - AUC0-t (Doxylamine) |
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - AUC0-t (Pyridoxal-5-phosphate) |
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - AUC0-inf (Doxylamine) |
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - AUC0-inf (Pyridoxal-5-phosphate) |
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - AUCextr (Doxylamine) |
Extrapolated AUC, defined as (AUC0-inf - AUC0-t)/AUC0-inf |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - AUCextr (Pyridoxal-5-phosphate) |
Extrapolated AUC, defined as (AUC0-inf - AUC0-t)/AUC0-inf |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - t1/2 (Doxylamine) |
Elimination half-life (t1/2) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - t1/2 (Pyridoxal-5-phosphate) |
Elimination half-life (t1/2) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - kel (Doxylamine) |
Elimination constant (kel) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - kel (Pyridoxal-5-phosphate) |
Elimination constant (kel) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - MRT (Doxylamine) |
Mean residence time (MRT) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Pharmacokinetics - MRT (Pyridoxal-5-phosphate) |
Mean residence time (MRT) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Bioequivalence - ratio of Cmax (Doxylamine) |
Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Bioequivalence - ratio of Cmax (Pyridoxal-5-phosphate) |
Ratio of geometric mean Cmax after intake of R or T (with 90% confidence intervals) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Bioequivalence - ratio of AUC0-t (Doxylamine) |
Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Bioequivalence - ratio of AUC0-t (Pyridoxal-5-phosphate) |
Ratio of geometric mean AUC0-t after intake of R or T (with 90% confidence intervals) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Bioequivalence - ratio of AUC0-inf (Doxylamine) |
Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Primary |
Bioequivalence - ratio of AUC0-inf (Pyridoxal-5-phosphate) |
Ratio of geometric mean AUC0-inf after intake of R or T (with 90% confidence intervals) |
From 0 to 72 hours (Day 1-4 and Day 22-25) |
|
Secondary |
Safety and Tolerability: adverse event (AE) number and frequency |
Number and frequency of adverse events (AEs) |
From the screening (and signing informed consent form) to Day 29 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
serious adverse event (SAE) number and frequency |
Number and frequency of serious AEs (SAEs) |
From the screening (and signing informed consent form) to Day 29 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: vital signs - systolic blood pressure (SBP) |
SBP, mmHg |
Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: vital signs - diastolic blood pressure (DBP) |
DBP, mmHg |
Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: vital signs - respiratory rate (RR) |
RR, breaths per minute |
Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: vital signs - heart rate (HR) |
HR, beats per minute |
Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: vital signs - body temperature |
Body temperature, centigrade scale |
Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: physical examination results |
Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially. |
Screening, from Day 0 to Day 4, from Day 21 to Day 25, and/or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc) |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis - color |
Color of the urine |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis - transparency |
Transparency of the urine |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis - pH |
pH of the urine |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis - specific gravity |
Specific gravity of the urine |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis - protein |
Protein in the urine (g/L) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis - glucose |
Glucose in the urine (mmol/L) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - red blood cells |
Red blood cells in the urine (number in sight) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - white blood cells |
White blood cells in the urine (number in sight) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - epithelial cells |
Epithelial cells in the urine (number in sight) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - cylinders |
Cylinders in the urine (number in sight) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - mucus |
Mucus in the urine (presence in sight) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - bacteria |
Bacteria in the urine (number in sight) |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - hemoglobin |
Hemoglobin, g/dL |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - red blood cells |
Red blood cells, 10^6/uL |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - hematocrit |
Hematocrit, % |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - platelets |
Platelets, 10^3/uL |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - white blood cells |
White blood cells, 10^3/uL |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate |
Erythrocyte sedimentation rate, mm per hour |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - neutrophils |
Neutrophils, % |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - lymphocytes |
Lymphocytes, % |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - eosinophils |
Eosinophils, % |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - monocytes |
Monocytes, % |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: complete blood count - basophils |
Basophils, % |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - total protein |
Total protein in blood serum, g/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - creatinine |
Creatinine in blood serum, umol/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - glucose |
Glucose in blood serum, mmol/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - total bilirubin |
Total bilirubin in blood serum, umol/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - total cholesterol |
Total cholesterol in blood serum, mmol/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - alanine transaminase (ALT) |
ALT in blood serum, U/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - aspartate transaminase (AST) |
AST in blood serum, U/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|
Secondary |
Safety and Tolerability: blood test results - alkaline phosphatase (ALP) |
ALP in blood serum, U/L |
Screening, Day 4, Day 25 or on early termination visit within the time frame of the study (from Day 0 to Day 29) |
|