Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus oral administration at healthy volunteers.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Area-under- the-curve (AUC)
- Relative bioavailability (Frel= AUCrectal/AUCoral)
Secondary outcome
- Maximum concentation (Cmax)
- Time to maximum concentration (Tmax)
- Clearance (Cl)
- Volume of distribution (Vd)
- Elimination constant (Kel)
- Elimination half-life(T1/2)
Background summary
Less research has been done to the rectal administration of levetiracetam.
In only 2 case reports levetiracetam suspension was administered rectal.
From these dates becomes clear that levetiracetam is absorbed after rectal
administration. However the steady-state concentrations were lower than after
oral administration.
Study objective
Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus
oral administration at healthy volunteers.
Study design
Single-center, not-blinded, 2-period cross-over study with 12 healthy
volunteers.
Study burden and risks
Before participation the test persons have to fill in aquestionnaire en thet
have to give blood and urine for screening (blood: creatinine, ASAT, ALAT,
gammaGT, Hb en Ht; urine: protein, glucose, pH).
For the research itself, they should be in the hospital twice for a whole day
and twice for just one blood sample.
During research there will be administered once a tablet Keppra and once a
suppository levetiracetam.
Via a catheter blood will be taken on 14 fixed times (+/- 6 ml). The morning
after one blood sample will be taken.
During research there will be asked for possible adverse effects. The
expectation is that these will be minimal, because it's only one administration
of a low dose levetiracetam.
Henri Dunantstraat 5
6419PC Heerlen
NL
Henri Dunantstraat 5
6419PC Heerlen
NL
Listed location countries
Age
Inclusion criteria
healthy volunteers
18-55 years
conformed consent
Exclusion criteria
patients with epilepsia
pregnant women
breast feeding women
bad renal function
bad liver function
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2007-003243-76-NL |
CCMO | NL18256.096.07 |