Trial Outcomes & Findings for A Study in Healthy People to Compare Two Different Sifrol® Tablets (NCT NCT06457204)
NCT ID: NCT06457204
Last Updated: 2025-08-28
Results Overview
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.
COMPLETED
PHASE1
28 participants
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.
2025-08-28
Participant Flow
This was a randomized, open-label, two-way crossover design trial.
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
|
Period 1
COMPLETED
|
14
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
14
|
14
|
|
Washout
COMPLETED
|
14
|
12
|
|
Washout
NOT COMPLETED
|
0
|
2
|
|
Period 2
STARTED
|
14
|
12
|
|
Period 2
COMPLETED
|
14
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Washout
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Study in Healthy People to Compare Two Different Sifrol® Tablets
Baseline characteristics by cohort
| Measure |
Reference - Test
n=14 Participants
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.
|
Test - Reference
n=14 Participants
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim
n=26 Participants
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 - Sifrol® (Pramipexole) Manufactured in Ennigerloh
n=27 Participants
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.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
3573 hour * picogram per milliliter
Standard Error NA
Adjusted geometric standard error = 1.039
|
3632 hour * picogram per milliliter
Standard Error NA
Adjusted geometric standard error = 1.039
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim
n=26 Participants
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 - Sifrol® (Pramipexole) Manufactured in Ennigerloh
n=27 Participants
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.
|
|---|---|---|
|
Maximum Measured Concentration of Pramipexole in Plasma (Cmax)
|
285 picogram per milliliter
Standard Error NA
Adjusted geometric standard error = 1.037
|
280 picogram per milliliter
Standard Error NA
Adjusted geometric standard error = 1.036
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim
n=26 Participants
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 - Sifrol® (Pramipexole) Manufactured in Ennigerloh
n=27 Participants
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.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3730 hour * picogram per milliliter
Standard Error NA
Adjusted geometric standard error = 1.040
|
3788 hour * picogram per milliliter
Standard Error NA
Adjusted geometric standard error = 1.040
|
Adverse Events
Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim
Test - Sifrol® (Pramipexole) Manufactured in Ennigerloh
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference - Sifrol® (Pramipexole) Manufactured in Ingelheim
n=26 participants at risk
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 - Sifrol® (Pramipexole) Manufactured in Ennigerloh
n=28 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • 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.
|
10.7%
3/28 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • 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.
|
10.7%
3/28 • 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.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • 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.
|
0.00%
0/28 • 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.
|
|
Nervous system disorders
Headache
|
23.1%
6/26 • 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.
|
17.9%
5/28 • 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.
|
|
Nervous system disorders
Orthostatic intolerance
|
7.7%
2/26 • 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.
|
0.00%
0/28 • 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.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place