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Completed

NCT Number: NCT01119443

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

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

248.677.001 Boehringer Ingelheim Investigational Site

Sumida-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPX ER

Drug

PPX ER 0.375mg - 1.5mg for 32 days totally

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

Secondary outcomes

  1. Cτ,ss (Fed Conditions)

    Time frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration

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

  2. 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

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

  3. 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

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

  4. 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

    Terminal rate constant of the analyte in plasma at steady state

  5. 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

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

  6. 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

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

  7. Cτ,ss (Fasted Conditions)

    Time frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration

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

  8. 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

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

  9. 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

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

  10. 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

    Terminal rate constant of the analyte in plasma at steady state

  11. 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

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

  12. 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

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
First posted
May 7, 2010
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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