A Study in Healthy People to Compare Two Different Sifrol® Tablets

Boehringer Ingelheim28 enrolled

Overview

The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Pramipexole manufactured in IngelheimDRUG

1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Pramipexole manufactured in EnnigerlohDRUG

1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical histo1y including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 55 years (inclusive) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply. Exclusion Criteria: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Locations (1)

Humanpharmakologisches Zentrum Biberach

Biberach, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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 Outcomes

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.

Data from ClinicalTrials.gov

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