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

Phase 1CompletedNCT01119443

Boehringer Ingelheim28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PPX ERDRUG

PPX ER 0.375mg - 1.5mg for 32 days totally

PPX ERDRUG

PPX ER 0.375mg - 1.5mg for 32 days totally

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

248.677.001 Boehringer Ingelheim Investigational Site

Sumida-ku, Tokyo, Japan

Outcomes

Primary Outcomes

AUCτ,ss (Fed Conditions)

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ

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

Cmax,ss (Fed Conditions)

maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

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

AUCτ,ss (Fasted Conditions)

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ

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

Cmax,ss (Fasted Conditions)

maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

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

Secondary Outcomes

Cτ,ss (Fed Conditions)

Concentration of the analyte in plasma at time τ at steady state

Time frame: 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

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

Data from ClinicalTrials.gov

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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

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

λz,ss (Fed Conditions)

Terminal rate constant of the analyte in plasma at steady state

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

t1/2,ss (Fed Conditions)

Terminal half-life of the analyte in plasma at steady state

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

MRTpo,ss (Fed Conditions)

Mean residence time of the analyte in the body at steady state after oral administration

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

Cτ,ss (Fasted Conditions)

Concentration of the analyte in plasma at time τ at steady state

Time frame: 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

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

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

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

λz,ss (Fasted Conditions)

Terminal rate constant of the analyte in plasma at steady state

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

t1/2,ss (Fasted Conditions)

Terminal half-life of the analyte in plasma at steady state

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

MRTpo,ss (Fasted Conditions)

Mean residence time of the analyte in the body at steady state after oral administration

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