Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls

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 n=50).

Conditions

• Healthy Volunteers

Interventions

DRUG

Methylprednisone

12 mg of methylprednisone (3 pills of 4 mg each) administered orally in a single dose.

DRUG

Methylprednisone

12 mg of methylprednisone (3 pills of 4 mg each) administered orally every 24 hours during 3 days.

DRUG

Deflazacort

30 mg of deflazacort (1 pill) administered orally in a single dose.

DRUG

Dexamethasone

4 mg of dexamethasone (1 pill) administered orally in a single dose.

DRUG

Dexamethasone

2 mg of dexamethasone (1/2 pill) administered orally every 12 hours during 5 days.

Sponsors & Collaborators

• Parc de Salut Mar

  lead OTHER

Principal Investigators

• Rosa Ventura Alemany, PharmD, PhD · IMIM (Hospital del Mar Medical Research Institute)

• Ana M Aldea Perona, MD, PhD · IMIM (Hospital del Mar Medical Research Institute)

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-26

Primary Completion

2022-02-26

Completion

2022-02-26

Countries

• Spain

Study Locations