Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers

NCT02261103 | Completed Phase 1

• 1 other identifier: 248.530
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of the studies are:

• To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
• To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
• To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER

  up to 23 hours after drug application on day 5

• AUC0-24,ss for IR

  up to 23 hours after drug application on day 5

• Maximum measured concentration of the analyte in plasma at steady state (Cmax)

  up to 23 hours after drug application on day 5

• Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 4h at steady state (AUC0-4,ss) for ER

  up to 4 hours after drug application

Secondary Outcomes (17)

• Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)

  up to 23 hours after drug application on day 5

• Peak-Trough Fluctuation (PTF)

  up to 23 hours after drug application on day 5

• Time from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)

  up to 23 hours after drug application on day 5

• Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 h at steady state (AUC0-8,ss)

  up to 8 hours after drug application

• Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)

  predose on days 1 to 5

Study Arms (3)

Pramipexole IR, fasted

ACTIVE COMPARATOR

Pramipexole immediate release (IR) tablets

Drug: Pramipexole IR tablets; Drug: Placebo matching Pramipexole ER tablets

Pramipexole ER, fasted

EXPERIMENTAL

Pramipexole extended release (ER) tablets

Drug: Pramipexole ER tablets; Drug: Placebo matching Pramipexole IR tablets

Pramipexole ER, fed

EXPERIMENTAL

Pramipexole extended release tablets with a high-fat meal 30 min before drug administration

Drug: Pramipexole ER tablets; Other: Standard high-fat breakfast

Interventions

Pramipexole ER tablets DRUG

Pramipexole ER, fasted; Pramipexole ER, fed

Pramipexole IR tablets DRUG

Pramipexole IR, fasted

Placebo matching Pramipexole ER tablets DRUG

Pramipexole IR, fasted

Placebo matching Pramipexole IR tablets DRUG

Pramipexole ER, fasted

Standard high-fat breakfast OTHER

Pramipexole ER, fed

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants in the study should be healthy males
• Age range from 21 to 50 years
• Body mass index (BMI) be within 18.5 to 29.9 kg/m2
• In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug (≤ one month prior to administration or during the trial)
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on in-house trial days
• Alcohol abuse (\> 40 g/day)
• Drug abuse
• Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
• Any laboratory value outside the clinically accepted reference range

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 10, 2014
• Study Start: April 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: October 10, 2014

Record last verified: 2014-10