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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510764-23-00 | Registry Identifier | CTIS | |
| U1111-1303-3852 | Registry Identifier | WHO Registry (ICTRP) |
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The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference - Test | Experimental | Subjects received the reference product followed by the test product, the treatments were separated by a wash-out phase of at least 3 days. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
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| Test - Reference | Experimental | Subjects received the test product followed by the reference product, the treatments were separated by a wash-out phase of at least 3 days. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole manufactured in Ingelheim | Drug | 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of pramipexole in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration. |
| Maximum Measured Concentration of Pramipexole in Plasma (Cmax) | Maximum measured concentration of pramipexole in plasma (Cmax). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of pramipexole in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | 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: https://www.mystudywindow.com/msw/datatransparency
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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 was a randomized, open-label, two-way crossover design trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference - Test | Subjects received the reference product followed by the test product, the treatments were separated by a wash-out phase of at least 3 days. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
| FG001 | Test - Reference | Subjects received the test product followed by the reference product, the treatments were separated by a wash-out phase of at least 3 days. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout |
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| Period 2 |
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Treated set (TS): All subjects who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference - Test | Subjects received the reference product followed by the test product, the treatments were separated by a wash-out phase of at least 3 days. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
| 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 Pramipexole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of pramipexole in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Pharmacokinetic set (PKS): all subjects in the TS who provided 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 nonevaluability. | Posted | Geometric Least Squares Mean | Standard Error | hour * picogram per milliliter | Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration. |
Adverse events: up to 2 days following drug intake. All-cause mortality: up to 24 days.
Treated set (TS): All subjects who were treated with at least one 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 | Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim | Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 001 | 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 | Apr 29, 2024 | Aug 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2024 | Aug 11, 2025 | SAP_001.pdf |
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| Pramipexole manufactured in Ennigerloh | Drug | 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
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| Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration. |
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| NOT COMPLETED |
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| BG001 | Test - Reference | Subjects received the test product followed by the reference product, the treatments were separated by a wash-out phase of at least 3 days. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
| 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 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim | Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
| OG001 | Test - Sifrol® (Pramipexole) Manufactured in Ennigerloh | Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. |
|
|
|
| Primary | Maximum Measured Concentration of Pramipexole in Plasma (Cmax) | Maximum measured concentration of pramipexole in plasma (Cmax). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Pharmacokinetic set (PKS): all subjects in the TS who provided 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 nonevaluability. | Posted | Geometric Least Squares Mean | Standard Error | picogram per milliliter | Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of pramipexole in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Pharmacokinetic set (PKS): all subjects in the TS who provided 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 nonevaluability. | Posted | Geometric Least Squares Mean | Standard Error | hour * picogram per milliliter | Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration. |
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|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 7 |
| 26 |
| EG001 | Test - Sifrol® (Pramipexole) Manufactured in Ennigerloh | Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. | 0 | 28 | 0 | 28 | 5 | 28 |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Orthostatic intolerance | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Other |
| Other |