Last updated: 11/07/2018 15:10:21
A four-period cross-over study to assess the absolute bioavailability, safety and tolerability of the pentasaccharide Org31540/SR90107A, after single dose subcutaneous administration of 2, 4 and 8 mg compared with 4 mg intravenous administration to healthy elderly subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A four-period cross-over study to assess the absolute bioavailability, safety and tolerability of the pentasaccharide Org31540/SR90107A, after single dose subcutaneous administration of 2, 4 and 8 mg compared with 4 mg intravenous administration to healthy elderly subjects
Trial description: A four-period cross-over study to assess the absolute bioavailability, safety and tolerability of the pentasaccharide Org31540/SR90107A, after single dose subcutaneous administration of 2, 4 and 8 mg compared with 4 mg intravenous administration to healthy elderly subjects
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:
F Donat. The pharmacokinetics of fondaparinux sodium in healthy volunteers. Clin Pharmacokinet 2002;41 sup.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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