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Microdosing cinical studies -Assesment of oral bioavailability of drugs by cassete IV and PO dosing-

Microdosing cinical studies -Assesment of oral bioavailability of drugs by cassete IV and PO dosing- - Cassete microdosing study for assement of bioavailability using 3 calcium antagonisits

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002578
Enrollment
8
Registered
2009-10-03
Start date
2009-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension, arrhythmia

Interventions

Single IV cassete microdosing of nifedipine, nicardipine and diltiazem Single oral cassete microdosing of nifedipine, nicardipine and diltiazem Single oral clinical dosing of nifedipine Single oral

Sponsors

Oita university hospital,Clinical pharmacology center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Healthy male volunteers who are 20~40 years old 2) BMI 18.0~30.0

Exclusion criteria

Exclusion criteria: 1)person who has present and/or past history of disease of heart and circulatory system, liver,kidney and uretary system, and digestive system. 2)person who has drug adiction and/or allergy 3)person who takes drugs which has an effect on the result of this study 4)person who is thoght by medical doctor as unsuitable in physical examinations and blood and biochemistry examinations. 5)person who takes drugs and/or health food product like St.John's wort within 7 days before taking study drugs 6)person who juice wfruit within 7 days before taking study drugs including grapefruitjuice 7)person who usually take health food product like St.John's wort 8)person who joined other clinical study within 3 months before this study and is thougt as unsuitable by medical doctor 9)person who donated blood of 200mL within one month and within 3 months before this study 10)person who is positive HBV,HCV,HIV and syphilis 11)person who has allergy of drug and/or food 12)person who addict drugs and alcohol 12)person who is diagonosed by medical doctors as unsuitable for joinining this study

Design outcomes

Primary

MeasureTime frame
Each Cmax,Tmax,AUC 0-T,ACUinf, and of T1/2 of nifedipine, nicardipine and diltiazem

Countries

Japan

Contacts

Public ContactTAKUYA MORIMOTO

Oita university hospital Clinical pharmacology center

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026