Last updated: 11/07/2018 15:10:10
A repeated rising-dose, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A administered for 7 consecutive days to healthy male and female elderly volunteers
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A repeated rising-dose, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A administered for 7 consecutive days to healthy male and female elderly volunteers
Trial description: A repeated rising-dose, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A administered for 7 consecutive days to healthy male and female elderly volunteers
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Pharmacokinetics of fondaparinux in young and elderly healthy subjects: a highly favourable pharmacokinetic profile. Donat, F, Duret, J P, Sanotoni, A, Cariou, R, Necciari, J, Magnani, H, and de Greef, R 20th World Congress of the International Union of Angiology 4/7/2002 New York, USA
Abstract: Pharmacokinetics of fondaparinux sodium in young and elderly healthy subjects: a highly favourable profile. Donat, F, Duret, J P, Santoni, A, Cariou, R, Necciari, J, Magnani, H, de Greef, R, and Alban, S 7th Congress of the European Association of Hospital Pharmacists 3/20/2002 Vienna, Austria
Boneu B. Pharmacokinetics and tolerance of the natural pentasaccharide (SR90107A/ORG31540) with high affinity to antithrombin III in man. Thromb Haemost 74 (6):1468-1473, 1995
The pharmacokinetics of fondaparinux sodium in healthy volunteers. Donat, F., Duret, J. P., Santoni, A., Cariou, R., Necciari, J., Magnani, H., and de Greef, R. Clin Pharmacokinet 2002; 41 Suppl 2(1-9)
Medical condition
Healthy Subjects
Product
Not applicable
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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