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Not yet recruiting NCT07727785

A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sifrol®, Mirapex®.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bioequivalence of Two Pramipexole Tablets Following Oral Administration in Healthy Participants (an Open-label, Randomised, Multiple-dose, Two-way Crossover Trial)

Overview

The goal of this study is to find out whether pramipexole tablets made at two different production sites are handled in the same way by the body.

Interventions

  • Drug Sifrol®
    Pramipexole tablets
  • Drug Mirapex®
    Pramipexole tablets

Primary outcome measures

  • Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [Time frame: Up to Day 11]
  • Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [Time frame: Up to Day 11]
Secondary outcome measures (7)
  • Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) [Time frame: Up to Day 11]
  • Time from dosing to minimum measured concentration of the analyte in plasma at steady state within a uniform dosing interval τ (tmin,ss) [Time frame: Up to Day 11]
  • Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss) [Time frame: Up to Day 11]
  • Average concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cavg) [Time frame: Up to Day 11]
  • Measured concentration of the analyte in plasma at steady state at timepoint (= end of interval) τ (Cτ,ss) [Time frame: Up to Day 11]
  • Peak-trough fluctuation (PTF) [Time frame: Up to Day 11]
  • Peak-trough swing (PTS) [Time frame: Up to Day 11]

Eligibility criteria

Inclusion criteria

  • Healthy male or female trial participant 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)), and 12-lead electrocardiogram (ECG)
  • Age of 18 to 55 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
  • Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
  • Further inclusion criteria apply.

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeters of mercury (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)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Further exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Humanpharmakologisches Zentrum Biberach — Biberach

Identifiers

NCT: NCT07727785 · 0248-0690 · U1111-1335-9014 · 2026-525704-98

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗