In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers

NCT02260024 | Completed Phase 1

• 1 other identifier: 248.560
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)

  Up to 30 hours after drug administration

• Cmax (maximum measured concentration of pramipexole in blood plasma)

  Up to 30 hours after drug administration

Secondary Outcomes (14)

• AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)

  Up to 30 hours after drug administration

• AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),

  Up to 24 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),

  Up to 30 hours after drug administration

• tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)

  Up to 30 hours after drug administration

• λz (terminal rate constant in blood plasma),

  Up to 30 hours after drug administration

Study Arms (6)

Pramipexole IR

ACTIVE COMPARATOR

Drug: Pramipexole IR tablets

Pramipexole SR C2 in the fasted state

EXPERIMENTAL

Drug: Pramipexole SR C2

Pramipexole SR C2A in the fasted state

EXPERIMENTAL

Drug: Pramipexole SR C2A

Pramipexole SR C2B in the fasted state

EXPERIMENTAL

Drug: Pramipexole SR C2B

Pramipexole SR C in the fasted state

EXPERIMENTAL

Drug: Pramipexole SR C

Pramipexole SR C2 in the fed state

EXPERIMENTAL

Other: High fat, high caloric meal; Drug: Pramipexole SR C2

Interventions

High fat, high caloric meal OTHER

Pramipexole SR C2 in the fed state

Pramipexole IR tablets DRUG

Pramipexole IR

Pramipexole SR C DRUG

Pramipexole SR C in the fasted state

Pramipexole SR C2 DRUG

Pramipexole SR C2 in the fasted state; Pramipexole SR C2 in the fed state

Pramipexole SR C2A DRUG

Pramipexole SR C2A in the fasted state

Pramipexole SR C2B DRUG

Pramipexole SR C2B in the fasted state

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects as determined by results of the screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age ≥ 18 and ≤ 50 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2

You may not qualify if:

• Hypersensitivity to pramipexole or to other dopamine agonists
• Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure lower than 60 mmHg at screening
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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 7, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2005
• Primary Completion: December 1, 2005
• Last Updated: October 9, 2014

Record last verified: 2014-10