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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01119443
First received: May 5, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PPX ER
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUCτ,ss (Fed Conditions) [ 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 (Fed Conditions) [ 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

  • AUCτ,ss (Fasted Conditions) [ 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 (Fasted Conditions) [ 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


Secondary Outcome Measures:
  • Cτ,ss (Fed Conditions) [ 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 (Fed Conditions) [ 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

  • Tmax,ss (Fed Conditions) [ 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 (Fed Conditions) [ 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 (Fed Conditions) [ 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 (Fed Conditions) [ 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

  • Cτ,ss (Fasted Conditions) [ 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 (Fasted Conditions) [ 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

  • Tmax,ss (Fasted Conditions) [ 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 (Fasted Conditions) [ 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 (Fasted Conditions) [ 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 (Fasted Conditions) [ 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


Enrollment: 28
Study Start Date: April 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: PPX ER
PPX ER 0.375mg - 1.5mg for 32 days totally
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
Drug: PPX ER
PPX ER 0.375mg - 1.5mg for 32 days totally

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119443

Locations
Japan
248.677.001 Boehringer Ingelheim Investigational Site
Sumida-ku, Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01119443     History of Changes
Other Study ID Numbers: 248.677
Study First Received: May 5, 2010
Results First Received: May 30, 2011
Last Updated: March 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Pramipexol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 17, 2014