Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791345
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-03-05
Brief Title:
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DACORSIN4
Brief Summary:
Background
Glucocorticoids GC were included in the list of banned substances in sports in 1986 because of evidences of positive effects on physical performance and the important health risks associated with its consumption
Due to the fact that GC are commercialized in a variety of pharmaceutical forms and are administered in different ways it is necessary to establish discrimination criteria to guarantee the therapeutic use of these drugs and to prevent doping
Hypothesis
Discrimination criteria between allowed and prohibited administrations of GC must be specific for each of the compounds Further studies are needed to provide discrimination criteria related to oral administration of GC
Objectives
To conduct excretion studies with dexamethasone methylprednisolone and deflazacort in order to define notification levels and wash-out periods after the administration of a single dose DEX MP and DEF or repeated doses DEX and MP of these drugs
Methods
Non-randomized open-label pharmacokinetics clinical trial where a single dose of DEF MP and DEX and also a multi-dose of DEX and MP will be administered orally to healthy volunteers total n50
Glucocorticoids GC were included in the list of banned substances in sports in 1986 because of evidences of positive effects on physical performance and the important health risks associated with its consumption
Due to the fact that GC are commercialized in a variety of pharmaceutical forms and are administered in different ways it is necessary to establish discrimination criteria to guarantee the therapeutic use of these drugs and to prevent doping
Hypothesis
Discrimination criteria between allowed and prohibited administrations of GC must be specific for each of the compounds Further studies are needed to provide discrimination criteria related to oral administration of GC
Objectives
To conduct excretion studies with dexamethasone methylprednisolone and deflazacort in order to define notification levels and wash-out periods after the administration of a single dose DEX MP and DEF or repeated doses DEX and MP of these drugs
Methods
Non-randomized open-label pharmacokinetics clinical trial where a single dose of DEF MP and DEX and also a multi-dose of DEX and MP will be administered orally to healthy volunteers total n50
Detailed Description:
The World Anti-Doping Agency WADA has established a general notification level of 30 ngmL for GC to discriminate allowed and not allowed administrations However recent studies have proven that the use of a unique criteria is not adequate given the diversity of administration routes doses and pharmacokinetics and pharmacodynamics properties of each drug
The goal of this study is to conduct additional studies using dexamethasone DEX methylprednisolone MP and deflazacort DEF in order to generate additional data of urinary concentrations and wash-out periods after single and repeated oral doses of these drugs
The goal of this study is to conduct additional studies using dexamethasone DEX methylprednisolone MP and deflazacort DEF in order to generate additional data of urinary concentrations and wash-out periods after single and repeated oral doses of these drugs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None