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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004806-24 | EudraCT Number |
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The main objective of Part 1of this trial is to investigate the effect of co-administration of multiple doses of donepezil on the single-dose pharmacokinetics of BI 425809 in healthy subjects. In Part 2 the main objective is the investigation of the effect of co-administration of multiple doses of BI 425809 on the single-dose pharmacokinetics of donepezil in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 | Drug | Film coated tablet |
| |
| Donepezil |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) plasma concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil. | Detailed time frame is in the description section |
| Area Under the Concentration-time Curve of Donepezil in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured within 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809. | Detailed time frame is in the description section |
| Maximum Measured Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma (Cmax). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil. | Detailed time frame is in the description section |
| Maximum Measured Concentration of Donepezil in Plasma (Cmax) | Maximum measured concentration of donepezil in plasma (Cmax). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured withing 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil. |
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Inclusion Criteria:
Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Male subjects, or female subjects who meet any of the following criteria from the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| 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, except for the following exclusions:
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This is an open-label, two-treatment, two-period, one fixed sequence cross-over design study in order to investigate the effects of donepezil (Don) on the pharmacokinetics (PK) of BI 425809 (trial part 1) and vice versa (trial part 2) in healthy male and female subjects over a period up to 57 days in part 1 and up to 55 days in part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trial Part 1: BI 425809 / Donepezil + BI 425809 | All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid. |
| FG001 | Trial Part 2: Donepezil / BI 425809 + Donepezil | All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 for Trial Part 1 and 2 |
| |||||||||||||
| Period 2 for Trial Part 1 and 2 |
|
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trial Part 1: BI 425809 / Donepezil + BI 425809 | All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid. |
| 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 | Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) plasma concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been 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. | Posted | Geometric Mean | Standard Error | nanomoles * hours per liter | Detailed time frame is in the description section |
|
The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
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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 | BI 425809 Alone Group (Part 1: Treatment A, Reference 1) | All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment A, Reference 1). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 22.0 | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2019 | Jan 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2019 | Jan 26, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000634404 | BI 425809 |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
Film coated tablet |
|
| Detailed time frame is in the description section |
| Detailed time frame is in the description section |
| Area Under the Concentration-time Curve of Donepezil in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured within 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809. | Detailed time frame is in the description section |
| NOT COMPLETED |
|
|
| BG001 | Trial Part 2: Donepezil / BI 425809 + Donepezil | All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| BI 425809 Alone Group (Part 1: Treatment A, Reference 1) |
All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment A, Reference 1). |
| OG001 | BI 425809 + Don Group (Part 1: Treatment B, Test 1) | All participants were orally administered a single dose of BI 425809, 25 mg, film-coated tablet, on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) once a day (qd) on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1). |
|
|
|
| Primary | Area Under the Concentration-time Curve of Donepezil in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured within 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been 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. | Posted | Geometric Mean | Standard Error | nanograms * hours per milliliter | Detailed time frame is in the description section |
|
|
|
|
| Primary | Maximum Measured Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma (Cmax). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been 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. | Posted | Geometric Mean | Standard Error | nanomoles per liter | Detailed time frame is in the description section |
|
|
|
|
| Primary | Maximum Measured Concentration of Donepezil in Plasma (Cmax) | Maximum measured concentration of donepezil in plasma (Cmax). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured withing 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been 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. | Posted | Geometric Mean | Standard Error | nanograms per milliliter | Detailed time frame is in the description section |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been 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. | Posted | Geometric Mean | Standard Error | nanomoles * hours per liter | Detailed time frame is in the description section |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of Donepezil in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured within 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been 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. | Posted | Geometric Mean | Standard Error | nanograms * hours per milliliter | Detailed time frame is in the description section |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | Donepezil Group (Part 1: Treatment B, Test 1) | All participants were orally administered multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1). | 0 | 18 | 0 | 18 | 15 | 18 |
| EG002 | BI 425809 + Donepezil Group (Part 1: Treatment B, Test 1) | All participants were orally administered a single dose of BI 425809, 25 mg, film-coated tablet, on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1). | 0 | 18 | 0 | 18 | 13 | 18 |
| EG003 | Donepezil Alone Group (Part 2: Treatment C, Reference 2) | All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2). | 0 | 14 | 0 | 14 | 7 | 14 |
| EG004 | BI 425809 Group (Part 2: Treatment D, Test 2) | All participants were orally administered multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2). | 0 | 14 | 0 | 14 | 4 | 14 |
| EG005 | Donepezil + BI 425809 Group (Part 2: Treatment D, Test 2) | All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2). | 0 | 14 | 0 | 14 | 10 | 14 |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | 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 |