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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003152-16 | EudraCT Number |
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The main objective of this trial is to assess single dose drug exposure of several newly developed formulation prototypes of Nintedanib compared to Ofev® following oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Each participant received: Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2), compared to the reference (R) treatment: Nintedanib formulation 3: Ofev®. |
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| Cohort 2 | Experimental | Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2) compared to the reference (R) treatment: Nintedanib formulation 3: Ofev®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofev® | Drug | Ofev® |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Over the Time Interval From 0 Extrapolated to Infinity Which Includes Also the Second Nintedanib (Ofev®) Dose of the Day (AUC₀-∞) | The area under the concentration-time curve over the time interval from 0 [first dose] extrapolated to infinity (AUC₀-∞) was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC₀-tz) | The area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC₀-tz) was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. |
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Inclusion Criteria:
Healthy male subjects (Caucasian and Black only) according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiograms (ECG) and clinical laboratory tests.
Age of 18 to 55 years (inclusive).
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) and absolute body weight of at least 65 kg.
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
Non-smokers for at least 6 months.
Subjects who are sexually active must use with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:
Male subjects should not donate sperm for the duration of the study and for at least 30 days after last IMP administration. Male subjects with pregnant or lactating partners are allowed.
Exclusion Criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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Only participants that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All participants were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all participants was adhered to throughout the trial conduct. Rescue medication was allowed for all participants as required.
This trial was a randomised, open-label, crossover, single-dose (once daily [qd] for test and twice daily [bid] for reference treatment) study in up to 3 parts; trial part 1: 2 parallel groups (Cohort 1, Cohort 2), each a randomised three-period crossover; trial part 2 (optional): one group of randomised three-period crossover; trial part 3 (optional): one group of randomised two-period crossover. Parts 2 and 3 were not performed. The trial was stopped as per protocol during trial part 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: R | MR1-1 | MR1-2 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
Abbreviations: R=Reference=Ofev® capsules, MR1-1=Monolithic Nintedanib Modified Release Prototype 1 Tablet, MR1-2=Monolithic Nintedanib Modified Release Prototype 2 Tablet. |
| FG001 | Cohort 1: MR1-2 | R | MR1-1 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
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| FG002 | Cohort 1: MR1-1 | MR1-2 | R | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
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| FG003 | Cohort 2: R | MR2-1 | MR2-2 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
Abbreviations: R=Reference=Ofev® capsules, MR2-1=Polyox Nintedanib Modified Release Prototype 1 Tablet, MR2-2=Polyox Nintedanib Modified Release Prototype 2 Tablet. |
| FG004 | Cohort 2: MR2-2 | R | MR2-1 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
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| FG005 | Cohort 2: MR2-1 | MR2-2 | R | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Washout Period 1 |
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| Treatment Period 2 |
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| Washout Period 2 |
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| Treatment Period 3 |
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Treated set (TS): The treated set included all participants who were randomized and treated with at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: R | MR1-1 | MR1-2 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
Abbreviations: R=Reference=Ofev® capsules, MR1-1=Monolithic Nintedanib Modified Release Prototype 1 Tablet, MR1-2=Monolithic Nintedanib Modified Release Prototype 2 Tablet. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Area Under the Concentration-time Curve of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Over the Time Interval From 0 Extrapolated to Infinity Which Includes Also the Second Nintedanib (Ofev®) Dose of the Day (AUC₀-∞) | The area under the concentration-time curve over the time interval from 0 [first dose] extrapolated to infinity (AUC₀-∞) was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | Hours times nanogram per milliliter | Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration. |
From first drug administration in this period to at least 14 days thereafter OR until next drug administration of the following period, whatever occurred first, up to 22 days after last drug administration.
Treated set (TS): The treated set included all participants who were randomized and treated with at least one 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 | Cohort 1: Reference (R) | A low oral dose of Ofev® (Reference (R)) capsule bid was administered with 240 millilitre (ml) of water after a light breakfast and dinner, respectively on one day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
As per protocol Parts 2 and 3 were not performed. The trial was stopped as per protocol during trial Part 1.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2022 | May 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2023 | May 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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| Nintedanib formulation 1 | Drug | Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2). |
|
| Nintedanib formulation 2 | Drug | Nintedanib formulation 2: Polyox Nintedanib Modified Release Tablet (MR2) as two Prototypes (MR2-1 and MR2-2). |
|
| Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration. |
| Maximum Measured Concentration of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Within the 24h Dosing Interval (Cmax) | The maximum measured concentration in plasma was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Within 3 hours (h) prior and 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 13.0 (except MR1, MR2), 14.0, 15.0, 16.0, 17.0 (except R), 18.0, 20.0, 22.0, 24.0, 34.0, 48.0, 58.0, and 72 h after administration |
| Concentration of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma 24 Hours After the First Dose (C₂₄) | The measured concentration in plasma 24 hours after first administration was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
| BG001 | Cohort 1: MR1-2 | R | MR1-1 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
|
| BG002 | Cohort 1: MR1-1 | MR1-2 | R | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
|
| BG003 | Cohort 2: R | MR2-1 | MR2-2 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
Abbreviations: R=Reference=Ofev® capsules, MR2-1=Polyox Nintedanib Modified Release Prototype 1 Tablet, MR2-2=Polyox Nintedanib Modified Release Prototype 2 Tablet. |
| BG004 | Cohort 2: MR2-2 | R | MR2-1 | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
|
| BG005 | Cohort 2: MR2-1 | MR2-2 | R | In this arm participants were treated at 3 treatment visits (= 3 treatment periods). There was a washout period of at least 14 days between each treatment visit, i.e. the morning dose in the preceding treatment period and the morning dose in the following treatment period were separated by at least 14 days. Treatments:
|
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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|
|
|
| Secondary | Area Under the Concentration-time Curve of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC₀-tz) | The area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC₀-tz) was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | Hours times nanogram per milliliter | Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration. |
|
|
|
|
| Secondary | Maximum Measured Concentration of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma Within the 24h Dosing Interval (Cmax) | The maximum measured concentration in plasma was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | Nanogram per milliliter | Within 3 hours (h) prior and 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 13.0 (except MR1, MR2), 14.0, 15.0, 16.0, 17.0 (except R), 18.0, 20.0, 22.0, 24.0, 34.0, 48.0, 58.0, and 72 h after administration |
|
|
|
|
| Secondary | Concentration of 3 Different Formulations of Nintedanib (MR1, MR2 and Ofev®) in Plasma 24 Hours After the First Dose (C₂₄) | The measured concentration in plasma 24 hours after first administration was analyzed in 3 different formulations of Nintedanib (MR1, MR2 and Ofev®) and in two cohorts:
The adjusted geometric least squares mean and adjusted geometric standard error were calculated by an analysis of variance (ANOVA) model on the logarithmic scale. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | Nanogram per milliliter | Within 3 hours (h) prior and 1, 2, 3, 4, 6, 8, 10, 12, 13 (except MR1, MR2), 14, 15, 16, 17 (except R), 18, 20, 22, 24, 34, 48, 58, and 72 h after administration. |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | Cohort 1: Test Treatment 1 (MR1-1) | A single medium oral dose of Monolithic Nintedanib Modified Release Prototype 1 Tablet (MR1-1) was administered with 240 ml water in the morning after a light breakfast on one day. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Cohort 1: Test Treatment 2 (MR1-2) | A single medium oral dose of Monolithic Nintedanib Modified Release Prototype 2 Tablet (MR1-2) was administered with 240 ml water in the morning after a light breakfast on one day. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Cohort 2: Reference (R) | A low oral dose of Ofev® capsule (R) bid was administered with 240 ml of water after a light breakfast and dinner, respectively on one day. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG004 | Cohort 2: Test Treatment 1 (MR2-1) | A single medium oral dose of Polyox Nintedanib Modified Release Prototype 1 Tablet (MR2-1) was administered with 240 ml water in the morning after a light breakfast on one day. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG005 | Cohort 2: Test Treatment 2 (MR2-2) | A single medium oral dose of Nintedanib Polyox Nintedanib Modified Release Prototype 2 Tablet (MR2-2) was administered with 240 ml water in the morning after a light breakfast on one day. | 0 | 14 | 0 | 14 | 3 | 14 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
|
Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. |
| gMean Ratio |
| 12.41 |
| 2-Sided |
| 90 |
| 7.93 |
| 19.43 |
gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation [%] = 44.8 |
| Other |
| Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | gMean Ratio | 37.90 | 2-Sided | 90 | 29.25 | 49.11 | gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation [%] = 40.4 | Other |
| Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | gMean Ratio | 35.89 | 2-Sided | 90 | 27.66 | 46.55 | gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation [%] = 40.4 | Other |
|
Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. |
| gMean Ratio |
| 23.94 |
| 2-Sided |
| 90 |
| 13.51 |
| 42.42 |
gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation [%] = 58.8 |
| Other |
| Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | gMean Ratio | 68.55 | 2-Sided | 90 | 50.07 | 93.86 | gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation [%] = 50.0 | Other |
| Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | gMean Ratio | 66.85 | 2-Sided | 90 | 48.77 | 91.64 | gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation [%] = 50.0 | Other |
|
Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. |
| gMean Ratio |
| 13.98 |
| 2-Sided |
| 90 |
| 10.59 |
| 18.46 |
gMean ratio: MR1-2/R. Intra-individual Geometric coefficient of variation [%] = 23.5 |
| Other |
| Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | gMean Ratio | 32.13 | 2-Sided | 90 | 26.46 | 39.01 | gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation [%] = 29.3. | Other |
| Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | gMean Ratio | 31.38 | 2-Sided | 90 | 25.71 | 38.30 | gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation [%] = 29.3. | Other |