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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1659 | Ferric maltol capsule Wiki | 1.00 |
| drug535 | BRII-196 Wiki | 1.00 |
| drug1660 | Ferric maltol suspension Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.
Description: Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.
Measure: Ratio of maximum serum concentration (Cmax) of total iron in fasted condition Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted conditionDescription: Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Measure: Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed conditionDescription: Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension
Measure: Ratio of area under the curve (AUClast) of total serum iron in combined period of fasted condition Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted conditionDescription: Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Measure: Ratio of area under the curve (AUClast) of total serum iron in combined period of fed condition Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed conditionDescription: Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted)
Measure: PK analysis of total serum iron concentration; AUCinf in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of baseline corrected serum iron concentration; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of baseline corrected serum iron concentration; area under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of baseline corrected serum iron concentration; AUClast in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of baseline corrected serum iron concentration; Area Under the Curve from 0-infinity by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of baseline corrected serum iron concentration; AUCinf in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of maltol glucuronide; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of maltol glucuronide; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of maltol glucuronide; AUClast in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of maltol; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of maltol; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of maltol; AUClastin fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of TSAT; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of transferrin saturation; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of TSAT; AUClast in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of TIBC; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Total Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of TIBC; AUClast in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted)
Measure: Summary of Serious Adverse Events Time: up to 2 weeks following last doseDescription: Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of UIBC; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of Unsaturated Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of UIBC; AUClast in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of transferrin; Cmax in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Descriptive statistics of transferrin; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measure: PK analysis of transferrin; AUClast in fasted and fed conditions Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-doseDescription: Changes in Haemoglobin; change calculated as difference in values measured at Screening, predose and on Day 8, pre-dose by formulation (suspension or capsule) and condition (fed or fasted)
Measure: Changes in Hb from screening to Day 8 Time: Screening to Day 8Description: Descriptive summary of incidence and casual relationship of treatment-emergent serious adverse events according to MedDRA preferred term (PT) and system organ class (SOC)
Measure: Treatment-Emergent Adverse Events Time: From first dose of ferric maltol on Day 1 to study completionDescription: Descriptive summary of incidence and casual relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC)
Measure: TEAE leading to premature discontinuation of study drug/PK assessments Time: From first dose of ferric maltol on Day 1 to study completionDescription: Descriptive statistics for changes in blood pressure from Screening to Day 8
Measure: Vital signs - blood pressure, change from Day 1 to Day 8, Pre-dose Time: Screening to Day 8Description: Descriptive statistics for changes in heart rate from Screening to Day 8
Measure: Vital signs - heart rate, change from Day 1 to Day 8, Pre-dose Time: Screening to Day 8Description: Number of concomitant medications by formulation (suspension or capsule)
Measure: Summary of concomitant medication by formulation Time: Day 1 to Day 8 (24 hrs post-dose of last dosing)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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