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

NCT01119443 | Completed Phase 1 Results

• 1 other identifier: 248.677
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Cτ,ss (Fed Conditions)

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

• Cmin,ss (Fed Conditions)

  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)

  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)

  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)

  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

Study Arms (2)

Treatment sequence A

OTHER

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

Treatment sequence B

OTHER

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

Interventions

PPX ER DRUG

PPX ER 0.375mg - 1.5mg for 32 days totally

Treatment sequence A

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese healthy male
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

248.677.001 Boehringer Ingelheim Investigational Site

Sumida-ku, Tokyo, Japan

Location

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Last Updated: June 9, 2014
• Results First Posted: June 27, 2011

Record last verified: 2014-05

Locations

JP (1)