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

NCT ID: NCT02260024

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pramipexole IR

Group Type: ACTIVE_COMPARATOR

Pramipexole IR tablets

Intervention Type: DRUG

Pramipexole SR C2 in the fasted state

Group Type: EXPERIMENTAL

Pramipexole SR C2

Intervention Type: DRUG

Pramipexole SR C2A in the fasted state

Group Type: EXPERIMENTAL

Pramipexole SR C2A

Intervention Type: DRUG

Pramipexole SR C2B in the fasted state

Group Type: EXPERIMENTAL

Pramipexole SR C2B

Intervention Type: DRUG

Pramipexole SR C in the fasted state

Group Type: EXPERIMENTAL

Pramipexole SR C

Intervention Type: DRUG

Pramipexole SR C2 in the fed state

Group Type: EXPERIMENTAL

High fat, high caloric meal

Intervention Type: OTHER

Pramipexole SR C2

Intervention Type: DRUG

Interventions

High fat, high caloric meal

Intervention Type: OTHER

Pramipexole IR tablets

Intervention Type: DRUG

Pramipexole SR C

Intervention Type: DRUG

Pramipexole SR C2

Intervention Type: DRUG

Pramipexole SR C2A

Intervention Type: DRUG

Pramipexole SR C2B

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
• Any laboratory value outside the clinically accepted reference range
• Excessive physical activities within the last week before the trial or during the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

248.560

Identifier Type: -

Identifier Source: org_study_id