Phase 1
Completed N=28
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
Source: ClinicalTrials.gov NCT01119443 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: AUCτ,ss (Fed Conditions) — 33.7; 32.3 ng·h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUCτ,ss (Fed Conditions) |
33.7; 32.3 | — |
| PRIMARY Cmax,ss (Fed Conditions) |
2.24; 2.13 | — |
| PRIMARY AUCτ,ss (Fasted Conditions) |
31.4; 33.6 | — |
| PRIMARY Cmax,ss (Fasted Conditions) |
2.13; 2.12 | — |
| SECONDARY Cτ,ss (Fed Conditions) |
0.711; 0.656 | — |
| SECONDARY Cmin,ss (Fed Conditions) |
0.676; 0.633 | — |
| SECONDARY Tmax,ss (Fed Conditions) |
5.67; 5.76 | — |
| SECONDARY λz,ss (Fed Conditions) |
0.0609; 0.0640 | — |
| SECONDARY t1/2,ss (Fed Conditions) |
11.4; 10.8 | — |
| SECONDARY MRTpo,ss (Fed Conditions) |
19.1; 18.4 | — |
| SECONDARY Cτ,ss (Fasted Conditions) |
0.654; 0.757 | — |
| SECONDARY Cmin,ss (Fasted Conditions) |
0.654; 0.757 | — |
| SECONDARY Tmax,ss (Fasted Conditions) |
4.24; 4.28 | — |
| SECONDARY λz,ss (Fasted Conditions) |
0.0520; 0.0474 | — |
| SECONDARY t1/2,ss (Fasted Conditions) |
13.3; 14.6 | — |
| SECONDARY MRTpo,ss (Fasted Conditions) |
21.2; 22.9 | — |
Eligibility 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
- 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
Data sourced from ClinicalTrials.gov (NCT01119443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.