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

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