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

• AUCτ,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
• Cmax,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

• AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

• Cτ,ss [ Time Frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration ] [ Designated as safety issue: No ]
  Concentration of the analyte in plasma at time τ at steady state
• Cmin,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
• Cmin,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
• λz,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  Terminal rate constant of the analyte in plasma at steady state
• t1/2,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  Terminal half-life of the analyte in plasma at steady state
• MRTpo,ss [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ] [ Designated as safety issue: No ]
  Mean residence time of the analyte in the body at steady state after oral administration

• Ct,ss (concentration of the analyte in plasma at time t at steady state), [ Time Frame: 30days ] [ Designated as safety issue: No ]
• tmax,ss (time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• tz,ss (terminal rate constant of the analyte in plasma at steady state) (if applicable) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• t1/2,ss (terminal half-life of the analyte in plasma at steady state) (if applicable) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• MRTpo,ss (mean residence time of the analyte in the body at steady state after po administration) (if applicable) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Physical examination, blood pressure and pulse rate in supine and sitting position, laboratory parameters, ECG findings, adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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.

• Treatment sequence A
  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
  Intervention: Drug: PPX ER
• Treatment sequence B
  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
  Intervention: Drug: PPX ER

Inclusion criteria:

• 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