Recruiting

Observational Study

Sponsor:

Université de Montréal

Code:

NCT03340168

Conditions

PHARMACOKINETICS

Eligibility Criteria

Sex: Female

Age: 25 - 50

Healthy Volunteers: Accepted

Interventions

Bisphenol-S

Study Details

Brief summary:

The time course of bisphenol S in plasma and urine will be monitored in female adults exposed to a single oral and dermal dose of bisphenol-S. Six female will be recruited. Blood and urine will be collected at specified times post-treatment. Bisphenol concentrations will be measured in those samples.

Conditions

PHARMACOKINETICS

Study ID

NCT03340168

Start date

Mar 5, 2018

Status verified date

May, 2018

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Female

Exclusion Criteria:

  • People with liver or kidney problems or cancer

Study Design

Enrollment

6 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Bisphenol-S kinetics - oral exposure

Six female volunteers will be exposed orally acute at the reference dose level(0.1 mg / kg bw). For the administration, the product will be dissolved in ethanol (100 mg / ml equivalent to 10 mg / 100 μl) and the solution will be deposited on a cookie (deposit of about 70 μl of solution on a cookie for an individual of 70 kg) and the ethanol is allowed to evaporate before giving each volunteer, with the subsequent consumption of 100 ml of water.

experimental: Bisphenol-S kinetics - dermal exposure

volunteers will be exposed dermally acute at a dose of 1 mg / kg bw. The solution will be applied to an area of 40 cm2 of the forearm and delimited by the indelible marker. The BPS will be added in suspension in an aqueous solution containing 1% of carboxymethylcellulose and administered in the form of drops (70 .mu.l for an individual of 70 kg). The treated area will be left uncoated and unwashed for a period of 4 hours. After 4 hours, the application area will be washed with water and soap. This type of application is therefore similar to an exposure of the general population via the skin (manipulation of cash receipts).

Interventions

Bisphenol-S

Oral and dermal exposure in volunteers

Primary outcome measure

  • Toxicokinetics of bisphenol-S [ Time Frame: 0-72 h post-treatment ]

Central Contacts and Locations

Central contacts

Locations

Université de Montréal

Recruiting

Montréal, Quebec, Canada, H3C3J7

Contacts

More Information

Sponsor

Université de Montréal

Last update posted

May 9, 2018

Last verified

May, 2018

Keywords

  • Bisphenol S, toxicokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2018-05-09.