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Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PPX ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT01119443
248.677

Details and patient eligibility

About

Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.

Enrollment

28 patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Japanese healthy male
  • 20 to 40 years of age
  • body mass index (BMI) between 17.6 and 26.4 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)

Exclusion criteria

  1. Any clinical relevance findings of the medical examination as follows

    1. Blood pressure (systolic blood pressure is lower than 110 mmHg and diastolic blood pressure is lower than 60 mmHg at the screening in either a supine or a sitting position),
    2. pulse rate,
    3. electrocardiogram [ECG]
    4. laboratory test parameters) of clinical relevance
  2. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

  3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

  4. History of orthostatic hypotension, fainting spells or blackouts

  5. Chronic or acute infections

Trial design

28 participants in 2 patient groups

Treatment sequence A
Other group
Description:
V4: PPX ER 1.5mg x 1 fed, V5: PPX ER 0.375mg x 4 fed, V6:: PPX ER 1.5mg x 1 fasted, V5: PPX ER 0.375mg x 4 fasted
Treatment:
Drug: PPX ER
Drug: PPX ER
Treatment sequence B
Other group
Description:
V4: PPX ER 0.375mg x 4 fed, V5: PPX ER 1.5mg x 1 fed, V6:: PPX ER 0.375mg x 4 fasted, V5: PPX ER 1.5mg x 1 fasted
Treatment:
Drug: PPX ER
Drug: PPX ER

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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