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Correlation between prednisolone in saliva and (unbound) prednisolone in blood in healthy adults

Correlation between prednisolone in saliva and (unbound) prednisolone in blood in healthy adults - PSBHA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33121
Enrollment
20
Registered
2009-07-02
Start date
2009-11-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Gezonde vrijwilligers Pharmacokinetics in healthy volunteers

Interventions

A single oral administration of an 80 mg prednisolone capsule.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-65 years

Exclusion criteria

Exclusion criteria: Use of medication that can influence pharmacokinetics of prednisolone * hormonal contraceptives * rifampicin * phenytoin * barbiturates * ketoconazole ;Conditons that can infuence pharmacokitetics of prednisolone * Pregnancy * Liver of renal dysfunction * Renal transplantation * Hyperthyroidism * Crohn's disease * Cushing's disease or syndrome * Chronic lesions of the oral mucosa or tongue Diabetes Mellitus

Design outcomes

Primary

MeasureTime frame
Prednisolone concentrations (nmol/L): a. serum (total) b. serum (unbound/free) c. saliva Measurements: before ingestion of 80 mg prednisolone and 1, 2, 3, 4, 5 and 6 hours after ingestion.

Secondary

MeasureTime frame
serum albumine level (g/L) serum corticosteroid binding globulin (CBG) level (mg/L)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)