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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119443
• Other study ID #: 248.677
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2010
• Last updated: June 3, 2014
• Start date: April 2010

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PPX ER
PPX ER 0.375mg - 1.5mg for 32 days totally
• PPX ER
PPX ER 0.375mg - 1.5mg for 32 days totally

Locations

Country	Name	City	State
Japan	248.677.001 Boehringer Ingelheim Investigational Site	Sumida-ku, Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt,ss (Fed Conditions)	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t	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	No
Primary	Cmax,ss (Fed Conditions)	maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t	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	No
Primary	AUCt,ss (Fasted Conditions)	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t	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	No
Primary	Cmax,ss (Fasted Conditions)	maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t	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	No
Secondary	Ct,ss (Fed Conditions)	Concentration of the analyte in plasma at time t at steady state	pharmacokinetic blood samples collected at t (23.833 hours) after drug administration	No
Secondary	Cmin,ss (Fed Conditions)	Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t	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	No
Secondary	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 t	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	No
Secondary	?z,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	No
Secondary	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	No
Secondary	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	No
Secondary	Ct,ss (Fasted Conditions)	Concentration of the analyte in plasma at time t at steady state	pharmacokinetic blood samples collected at t (23.833 hours) after drug administration	No
Secondary	Cmin,ss (Fasted Conditions)	Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t	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	No
Secondary	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 t	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	No
Secondary	?z,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	No
Secondary	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	No
Secondary	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	No

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