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A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 | Experimental | Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) |
|
| Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 | Experimental | Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) |
|
| Glycopyrronium (GP) Dose 1 | Experimental | Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) |
|
| Glycopyrronium (GP) Dose 2 | Experimental | Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 | Drug | Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax) | Day 1 |
| Cmax | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax) | Day 1 |
| AUC 0-12 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12) | Day 1 |
| AUC 0-12 | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12) | Day 1 |
| AUC 0-t | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t) | Day 1 |
| AUC 0-t | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t) | Day 1 |
| AUC 0-∞ | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞) | Day 1 |
| AUC 0-∞ | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose | 12 Hours |
| Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose |
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Inclusion Criteria:
Informed Consent Form (ICF) prior to any study related procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadwick Orevillo | Pearl Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30218695 | Derived | Reisner C, Miller J, DePetrillo P, Maes A, Siddiqui S, Martin UJ. Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. Pulm Pharmacol Ther. 2018 Dec;53:33-38. doi: 10.1016/j.pupt.2018.09.005. Epub 2018 Sep 13. |
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Study was four-period, four-treatment, complete cross-over design in healthy adult Japanese Subjects. Each treatment visit was followed by a minimum 7 day to maximum 14 day washout period between treatments.
Conducted at 1 site from July 2014 - September 2014. Study duration for each subject was between 33 and 98 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Received GFF MDI 28.8/9.6 μg | Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg |
| FG001 | Received GFF MDI 14.4/9.6 μg | Received GFF MDI 14.4/9.6 μg |
| FG002 | Received GP MDI 28.8 μg | Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg |
| FG003 | Received GP MDI 14.4 μg | Received GP MDI 14.4 μg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis Set: All Subjects Randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Analysis Set: All Subjects Randomized |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | pg/mL | Day 1 |
|
Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GFF MDI 28.8/9.6 ug | Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Reisner, MD, FCCP, FAAAAI | Pearl Therapeutics Inc. | 650-305-2600 | creisner@pearltherapeutics.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 | Drug | Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) |
|
| Glycopyrronium (GP) Dose 1 | Drug | Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) |
|
| Glycopyrronium (GP) Dose 2 | Drug | Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID) |
|
| Tmax | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax) | Day 1 |
| Tmax | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax) | Day 1 |
| T 1/2 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2) | Day 1 |
| T 1/2 | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2) | Day 1 |
| CL/F | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment | Day 1 |
| CL/F | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment | Day 1 |
| Vd/F | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment | Day 1 |
| Vd/F | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment | Day 1 |
| Lambda z | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment | Day 1 |
| Lambda z | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment | Day 1 |
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)
| 12 Hours |
| Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin) | 12 Hours |
| Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes) | 12 Hours |
| Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose | 12 hours |
| Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR) | 12 hours |
| Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin) | 12 hours |
| Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose | 12 hours |
| Change in Heart Rate From Pre-dose to 12 Hours Post Dose | Change in Heart Rate from Pre-dose to 12 hours Post dose | 12 hours |
| Change in PR Interval From Pre-dose to 12 Hours Post Dose | Change in PR Interval from Pre-dose to 12 hours Post dose | 12 hours |
| Change in QRS Axis From Pre-dose to 12 Hours Post Dose | Change in QRS axis from Pre-dose to 12 hours Post dose | 12 hours |
| Change in QRS Duration From Pre-dose to 12 Hours Post Dose | Change in QRS duration from Pre-dose to 12 hours Post dose | 12 hours |
| Change in QT Interval From Pre-dose to 12 Hours Post Dose | Change in QT Interval from Pre-dose to 12 hours Post dose | 12 hours |
| Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose | Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose | 12 hours |
| Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose | Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose | 12 hours |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
GP MDI 28.8 ug
| OG003 | GP MDI 14.4 µg | GP MDI 14.4 µg |
|
|
| Primary | Cmax | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | pg/mL | Day 1 |
|
|
|
| Primary | AUC 0-12 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h*pg/mL | Day 1 |
|
|
|
| Primary | AUC 0-12 | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h*pg/mL | Day 1 |
|
|
|
| Primary | AUC 0-t | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h*pg/mL | Day 1 |
|
|
|
| Primary | AUC 0-t | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h*pg/mL | Day 1 |
|
|
|
| Primary | AUC 0-∞ | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h*pg/mL | Day 1 |
|
|
|
| Primary | AUC 0-∞ | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h*pg/mL | Day 1 |
|
|
|
| Primary | Tmax | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax) | Pharmacokinetic Population | Posted | Mean | Full Range | h | Day 1 |
|
|
|
| Primary | Tmax | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax) | Pharmacokinetic Population | Posted | Mean | Full Range | h | Day 1 |
|
|
|
| Primary | T 1/2 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h | Day 1 |
|
|
|
| Primary | T 1/2 | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2) | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | h | Day 1 |
|
|
|
| Primary | CL/F | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | L/h | Day 1 |
|
|
|
| Primary | CL/F | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | L/h | Day 1 |
|
|
|
| Primary | Vd/F | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | L | Day 1 |
|
|
|
| Primary | Vd/F | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | L | Day 1 |
|
|
|
| Primary | Lambda z | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | 1/h | Day 1 |
|
|
|
| Primary | Lambda z | Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment | Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte) | Posted | Mean | Full Range | 1/h | Day 1 |
|
|
|
| Secondary | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | 10^9cells/L | 12 Hours |
|
|
|
| Secondary | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | Ratio | 12 Hours |
|
|
|
| Secondary | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | g/L | 12 Hours |
|
|
|
| Secondary | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume) | Safety Population | Posted | Mean | Standard Deviation | fL | 12 Hours |
|
|
|
| Secondary | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin) | Safety Population | Posted | Mean | Standard Deviation | pg/cell | 12 Hours |
|
|
|
| Secondary | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes) | Safety Population | Posted | Mean | Standard Deviation | 10^12cells/L | 12 Hours |
|
|
|
| Secondary | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | IU/L | 12 hours |
|
|
|
| Secondary | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | g/L | 12 hours |
|
|
|
| Secondary | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | mmol/L | 12 hours |
|
|
|
| Secondary | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Standard Deviation | μmol/L | 12 hours |
|
|
|
| Secondary | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR) | Safety Population | Posted | Mean | Standard Deviation | mL/min/1.73m2 | 12 hours |
|
|
|
| Secondary | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin) | Safety Population | Posted | Mean | Standard Deviation | μg/L | 12 hours |
|
|
|
| Secondary | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose | Safety Population | Posted | Mean | Full Range | mmol/L | 12 hours |
|
|
|
| Secondary | Change in Heart Rate From Pre-dose to 12 Hours Post Dose | Change in Heart Rate from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | Beats/Min | 12 hours |
|
|
|
| Secondary | Change in PR Interval From Pre-dose to 12 Hours Post Dose | Change in PR Interval from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | msec | 12 hours |
|
|
|
| Secondary | Change in QRS Axis From Pre-dose to 12 Hours Post Dose | Change in QRS axis from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | QRS axis | 12 hours |
|
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|
| Secondary | Change in QRS Duration From Pre-dose to 12 Hours Post Dose | Change in QRS duration from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | msec | 12 hours |
|
|
|
| Secondary | Change in QT Interval From Pre-dose to 12 Hours Post Dose | Change in QT Interval from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | msec | 12 hours |
|
|
|
| Secondary | Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose | Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | msec | 12 hours |
|
|
|
| Secondary | Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose | Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose | Safety Population | Posted | Mean | Full Range | msec | 12 hours |
|
|
|
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | GFF MDI 14.4/9.6 ug | GFF MDI 14.4/9.6 ug | 0 | 23 | 8 | 23 |
| EG002 | GP MDI 28.8 ug | GP MDI 28.8 ug | 0 | 24 | 4 | 24 |
| EG003 | GP MDI 14.4 µg | GP MDI 14.4 µg | 0 | 24 | 4 | 24 |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
|
| Granulocytes (10^9cells/L) |
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| Leukocytes (10^9cells/L) |
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| Lymphocytes (10^9cells/L) |
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| Monocytes (10^9cells/L) |
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| Platelets (10^9cells/L) |
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| Granulocytes/leukocytes (ratio) |
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| Hematocrit (ratio) |
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| Lymphocytes/leukocytes (ratio) |
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| Monocytes/leukocytes (ratio) |
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| AST (IU/L) |
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| Gamma glutamyl transferase (IU/L) |
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| Chloride (mmol/L) |
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| Magnesium (mmol/L) |
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| Phosphorus (mmol/L) |
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| Sodium (mmol/L) |
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| Iron (μmol/L) |
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| Total bilirubin (μmol/L) |
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| Glucose (mmol/L) 2 hours post-dose |
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| Glucose (mmol/L) 4 hours post-dose |
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| Glucose (mmol/L) 12 hours post-dose |
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| Potassium (mmol/L) 30 minutes post-dose |
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| Potassium (mmol/L) 2 hours post-dose |
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| Potassium (mmol/L) 4 hours post-dose |
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| Potassium (mmol/L) 12 hours post-dose |
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