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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001694-40 | EudraCT Number |
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Part I:
To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306
Part II:
To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1) | Experimental | Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)). |
|
| Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2) | Experimental | Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2). |
|
| Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2) | Experimental | Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 409306 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: AUC0-tz of BI 409306 | Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point. | Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter. |
| Part 1: Cmax of BI 409306 | Maximum measured concentration of the BI 409306 in plasma. | Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter. |
| Part 2: AUC0-tz of Donepezil | Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point. | At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. |
| Part 2: Cmax of Donepezil | Maximum measured concentration of the donepezil in plasma. | At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: AUC 0-infinity of BI 409306 | Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity. | At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter. |
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Inclusion criteria:
intrauterine device (non-hormonal)
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
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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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All subjects were screened for eligibility to participate in the trial. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Removal of individual subjects if the subject withdrew consent for trial treatment or trial participation, without the need to justify the decision.
Part I (18 subjects entered) of this trial was performed as a one fixed sequence, open-label trial; single doses of BI 409306 and multiple doses of donepezil were administered. Part II (14 subjects entered) was performed as a randomised, open-label, 2-way crossover trial; single doses of donepezil and multiple doses of BI 409306 were administered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg Donepezil (T1) | This arm is used in part 1 of this trial only. The subjects received the treatments in a fixed sequence: Reference treatment (R1) / test treatment (T1). The test treatment (T1) was administered after preceding treatment with donepezil for 21 days. On day 1 of period 1, one film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (R1). In period 2, day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21 (up-titration regime). On day 1 of period 3, one film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (T1). There was no washout periods between the visits. |
| FG001 | Part 2: 5 mg Donepezil (R2) / 5 mg Donepezil + 100 mg BI 409306 (T2) | This arm is used in part 2 of this trial only. Each subject received first the reference treatment (R2) followed by a washout period of at least 25 days, followed by the test treatment (T2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state, followed by a washout period of at least 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 2, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily. |
| FG002 | Part 2: 5 mg Donepezil + 100 mg BI 409306 (T2) / 5mg Donepezil (R2) | This arm is used in part 2 of this trial only. Each subject received first the test treatment (T2) followed by a washout period of at least 25 days, followed by the reference treatment (R2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 1, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily, followed by a washout period of 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1, Period 1 |
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| Part 1, Period 2 |
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| Part 1, Period 3 |
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| Part 2, Period 1 |
| |||||||||||||
| Part 2, Washout |
| |||||||||||||
| Part 2, Period 2 |
|
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug. All 32 subjects of both trial parts were included in the TS. This subject set was used for the safety analysis and presentation of demographic and baseline characteristics and disposition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg Donepezil (T1) | This arm is used in part 1 of this trial only. The subjects received the treatments in a fixed sequence: Reference treatment (R1) / test treatment (T1). The test treatment (T1) was administered after preceding treatment with donepezil for 21 days. On day 1 of period 1, one film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (R1). In period 2, day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21 (up-titration regime). On day 1 of period 3, one film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (T1). There was no washout periods between the visits. |
| 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 | Part 1: AUC0-tz of BI 409306 | Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point. | Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol)*hour (h)/Litre (L) | Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter. |
|
From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial 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 | Part 1: 25 mg BI 409306 | One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C000630656 | BI 409306 |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Donepezil | Drug |
|
| Part 2: AUC0-infinity of Donepezil |
This outcome measure presents the area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity. |
| At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. |
| NOT COMPLETED |
|
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Part 2: 5 mg Donepezil (R2) / 5 mg Donepezil + 100 mg BI 409306 (T2) | This arm is used in part 2 of this trial only. Each subject received first the reference treatment (R2) followed by a washout period of at least 25 days, followed by the test treatment (T2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state, followed by a washout period of at least 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 2, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily. |
| BG002 | Part 2: 5 mg Donepezil + 100 mg BI 409306 (T2) / 5mg Donepezil (R2) | This arm is used in part 2 of this trial only. Each subject received first the test treatment (T2) followed by a washout period of at least 25 days, followed by the reference treatment (R2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 1, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily, followed by a washout period of 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 25 mg BI 409306 + 10 mg Donepezil | One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)). |
|
|
|
| Primary | Part 1: Cmax of BI 409306 | Maximum measured concentration of the BI 409306 in plasma. | Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter. |
|
|
|
|
| Primary | Part 2: AUC0-tz of Donepezil | Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point. | Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng)*h/ millilitre (mL) | At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. |
|
|
|
|
| Primary | Part 2: Cmax of Donepezil | Maximum measured concentration of the donepezil in plasma. | Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. |
|
|
|
|
| Secondary | Part 1: AUC 0-infinity of BI 409306 | Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity. | Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter. |
|
|
|
|
| Secondary | Part 2: AUC0-infinity of Donepezil | This outcome measure presents the area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity. | Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. |
|
|
|
|
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | Part 1: 5 mg Donepezil /10 mg Donepezil | Period 2: On day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21. | 0 | 18 | 15 | 18 |
| EG002 | Part 1: 25 mg BI 409306 25mg + 10 mg Donepezil | Period 3: One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)). | 0 | 17 | 5 | 17 |
| EG003 | Part 2: 5 mg Donepezil | One film-coated tablet of 5 mg donepezil (reference treatment 2 (R2)) was administered as single oral dose with 240 mL of water in the morning in fasted state. | 0 | 14 | 4 | 14 |
| EG004 | Part 2: 5mg Donepezil + 100 mg BI 409306 | One film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (test treatment 2 (T2)) were administered orally with 240 ml of water in the morning in fasted state on day 1. From day 2 to day 7, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily. | 0 | 14 | 12 | 14 |
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Chromatopsia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Visual brightness | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vessel puncture site thrombosis | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 19.0 | 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.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |