Overview
Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions
Status:
Completed
Completed
Trial end date:
2009-04-01
2009-04-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
The present study will be performed to investigate and to compare the in-vivo performance of the two investigational products Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic parameters after oral single dose administrations in the fasted and fed state.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
SocraTec R&D GmbHCollaborator:
SocraMetrics GmbHTreatments:
Nifedipine
Criteria
Inclusion Criteria:1. sex: male
2. ethnic origin: Caucasian
3. age: 18 - 55 years, inclusive
4. body-mass index (BMI): ³ 22 kg/m² and £ 27 kg/m²
5. good state of health (no clinically significant deviations from normal clinical
results and laboratory findings)
6. the subject must give written informed consent, after having been informed about
benefits and potential risks of the trial, as well as details of the insurance taken
out to cover the subject's participating in the study
Exclusion Criteria:
1. existing cardiac or haematological diseases and/or pathological findings, which might
interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
2. existing hepatic and/or renal diseases and/or pathological findings, which might
interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
3. existing gastrointestinal diseases and/or pathological findings, including severe
gastrointestinal or esophageal constriction or narrowing, which might interfere with
the drug's safety, tolerability, absorption and/or pharmacokinetics
4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS
and/or psychiatric disorders
5. relevant pathological changes in the ECG (12 standard leads) such as a second- or
third-degree AV block, complete bundle branch block, prolongation of the QRS complex
over 120 msec or the QTc-interval above 450 msec
6. known allergic or intolerance reactions to the active ingredient used or to
constituents of the pharmaceutical preparations (e.g. lactose intolerance)
7. subjects with severe allergies or multiple drug allergies
8. systolic blood pressure below 110 mmHg or above 155 mmHg
9. diastolic blood pressure below 60 mmHg or above 95 mmHg
10. resting heart rate in the awake subject below 45 bpm or above 90 bpm
11. laboratory values out of normal range unless the deviation from normal is judged as
not relevant for the study by the investigator
12. positive anti-HIV-test, HBs-AG-test or anti-HCV-test Lack of suitability for the trial
13. acute or chronic diseases which could affect absorption or metabolism
14. history of or current drug or alcohol dependence
15. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day
16. subjects who are on a diet which could affect the pharmacokinetics of the drug
17. regular intake of caffeine containing food or beverages of ≥ 500 mg (calculated as
caffeine) per day
18. heavy smokers (≥ 10 cigarettes per day or equivalents of other nicotine containing
products)
19. blood donation or other blood loss of more than 400 ml within the last two months
prior to the start of the study
20. participation in a clinical trial during the last two months prior to individual
enrolment of the subject
21. regular treatment with any systemically available medication (except hormonal
replacement therapy e.g. L-thyroxine)
22. subjects, who report a frequent occurrence of migraine attacks Administrative reasons
23. subjects suspected or known not to follow instructions
24. subjects who are unable to understand the written and verbal instructions, in
particular regarding the risks and inconveniences they will be exposed to as a result
of their participation in the study -