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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pramipexole SR C; Drug: Pramipexole SR C2; Other: High fat, high caloric meal; Drug: Pramipexole IR tablets; Drug: Pramipexole SR C2A; Drug: Pramipexole SR C2B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260024

248.560

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 6 patient groups

Pramipexole IR

Active Comparator group

Treatment:

Drug: Pramipexole IR tablets

Pramipexole SR C2 in the fasted state

Experimental group

Treatment:

Drug: Pramipexole SR C2

Pramipexole SR C2A in the fasted state

Experimental group

Treatment:

Drug: Pramipexole SR C2A

Pramipexole SR C2B in the fasted state

Experimental group

Treatment:

Drug: Pramipexole SR C2B

Pramipexole SR C in the fasted state

Experimental group

Treatment:

Drug: Pramipexole SR C

Pramipexole SR C2 in the fed state

Experimental group

Treatment:

Other: High fat, high caloric meal

Drug: Pramipexole SR C2