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NCT Number: NCT07727785

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sifrol®

Drug

Pramipexole tablets

Other names: Pramipexole

Mirapex®

Drug

Pramipexole tablets

Other names: Pramipexole

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss)

    Time frame: Up to Day 11

  4. Average concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cavg)

    Time frame: Up to Day 11

  5. Measured concentration of the analyte in plasma at steady state at timepoint (= end of interval) τ (Cτ,ss)

    Time frame: Up to Day 11

  6. Peak-trough fluctuation (PTF)

    Time frame: Up to Day 11

  7. Peak-trough swing (PTS)

    Time frame: Up to Day 11

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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