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

Study Overview
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Brief Summary
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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.

Official Title
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A Multiple Dose Study With Increasing Dose for Pramipexole Extended Release (ER) Tablet (0.375 mg q.d. to 1.5 mg q.d.) in Two-way Cross-over Comparison to Investigate the Bioequivalence of 1.5 mg ER x 1 Tablet q.d. Versus 0.375 mg ER x 4 Tablets q.d. Under Fasted and Fed Conditions in Japanese Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PPX ER
* Drug: PPX ER


Participation Criteria
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Eligibility Criteria
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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: Any clinical relevance findings of the medical examination as follows 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), pulse rate, electrocardiogram [ECG] laboratory test parameters) 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 acute infections

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment sequence A<br>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 | Drug: PPX ER<br>* PPX ER 0.375mg - 1.5mg for 32 days totally<br>|
| Other: Treatment sequence B<br>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 | Drug: PPX ER<br>* PPX ER 0.375mg - 1.5mg for 32 days totally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss (Fed Conditions) | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| Cmax,ss (Fed Conditions) | maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| AUCτ,ss (Fasted Conditions) | Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| Cmax,ss (Fasted Conditions) | maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cτ,ss (Fed Conditions) | Concentration of the analyte in plasma at time τ at steady state | pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration | 
| Cmin,ss (Fed Conditions) | Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| Tmax,ss (Fed Conditions) | Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| λz,ss (Fed Conditions) | Terminal rate constant of the analyte in plasma at steady state | 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 | 
| t1/2,ss (Fed Conditions) | Terminal half-life of the analyte in plasma at steady state | 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 | 
| MRTpo,ss (Fed Conditions) | Mean residence time of the analyte in the body at steady state after oral administration | 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 | 
| Cτ,ss (Fasted Conditions) | Concentration of the analyte in plasma at time τ at steady state | pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration | 
| Cmin,ss (Fasted Conditions) | Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| Tmax,ss (Fasted Conditions) | Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ | 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 | 
| λz,ss (Fasted Conditions) | Terminal rate constant of the analyte in plasma at steady state | 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 | 
| t1/2,ss (Fasted Conditions) | Terminal half-life of the analyte in plasma at steady state | 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 | 
| MRTpo,ss (Fasted Conditions) | Mean residence time of the analyte in the body at steady state after oral administration | 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 |