Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers

NCT02261090 | Completed Phase 1

• 1 other identifier: 248.529
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Plasma total exposure (AUCτ,ss)

  up to 168 hours after each drug administration

• Urine total exposure (Aeτ,ss)

  up to 168 hours after each drug administration

• Plasma maximum exposure (Cmax,ss)

  up to 168 hours after each drug administration

• Plasma minimum exposure (Cmin,ss)

  up to 168 hours after each drug administration

• Plasma average concentration (Cavg)

  up to 168 hours after each drug administration

• Plasma peak to trough fluctuation (PTF)

  up to 168 hours after each drug administration

Secondary Outcomes (12)

• AUC0-6,11 for the immediate release (IR) formulation

  day 7 of visit 2

• Cmax for the IR formulation

  up to 168 hours after drug administration in visit 2

• Cmin for the IR formulation

  up to 168 hours after drug administration in visit 2

• tmax for the IR formulation

  up to 168 hours after drug administration in visit 2

• Urinary excretion (Ae) for the IR formulation

  up to 168 hours after drug administration in visit 2

Study Arms (8)

Formulation B

EXPERIMENTAL

Slow release (SR) tablet

Drug: Formulation B: Pramipexole Slow release (SR) tablet

Formulation C

EXPERIMENTAL

SR tablet

Drug: Formulation C: Pramipexole Slow release tablet

Formulation D

EXPERIMENTAL

SR tablet

Drug: Formulation D: Pramipexole Slow release tablet

Formulation E

EXPERIMENTAL

SR tablet

Drug: Formulation E: Pramipexole Slow release tablet

Formulation F

EXPERIMENTAL

SR tablet

Drug: Formulation F: Pramipexole Slow release tablet

Formulation G

EXPERIMENTAL

SR tablet

Drug: Formulation G: Pramipexole Slow release tablet

Formulation H

EXPERIMENTAL

SR tablet

Drug: Formulation H: Pramipexole Slow release tablet

immediate release (IR) formulation

ACTIVE COMPARATOR

Drug: Pramipexole immediate release (IR) tablets

Interventions

Formulation B: Pramipexole Slow release (SR) tablet DRUG

Formulation B

Formulation C: Pramipexole Slow release tablet DRUG

Formulation C

Formulation D: Pramipexole Slow release tablet DRUG

Formulation D

Formulation E: Pramipexole Slow release tablet DRUG

Formulation E

Formulation F: Pramipexole Slow release tablet DRUG

Formulation F

Formulation G: Pramipexole Slow release tablet DRUG

Formulation G

Formulation H: Pramipexole Slow release tablet DRUG

Formulation H

Pramipexole immediate release (IR) tablets DRUG

immediate release (IR) formulation

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
• Participants should be ranging from 21 to 50 years of age
• Body mass index (BMI) 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 (≤ two months 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 (\> 60 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

MeSH Terms

Interventions

Tablets; Pramipexole

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• 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: June 1, 2004
• Primary Completion: September 1, 2004
• Last Updated: October 10, 2014

Record last verified: 2014-10