Pharmacogenetic and Pharmacokinetics of Naproxen and Associated Naproxen-esomeprazole

PHASE4CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 1, 2017

Primary Completion Date

October 1, 2017

Study Completion Date

October 1, 2017

Conditions
Poor Metabolizer Due to Cytochrome P450 CYP2C9 VariantPoor Metabolizer Due to Cytochrome p450 CYP2C19 Variant
Interventions
DRUG

Naproxen

20 phenotyped for CYP2C9 and CYP2C19 (by PCR) and for the pharmacokinetics of naproxen, saliva samples will be collected of these patients at different times after ingestion of a tablet of naproxen (500mg) (before, 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 5; 6; 8; 11; 24; 48; 72 e 96 hours after ingestion).

DRUG

Naproxen-esomeprazole

20 phenotyped for CYP2C9 and CYP2C19 (by PCR) and for the pharmacokinetics of naproxen-esomeprazole, saliva samples will be collected of these patients at different times after ingestion of a tablet of naproxen-esomeprazole (500mg+20mg) (after one month of the first collection) (before, 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 5; 6; 8; 11; 24; 48; 72 e 96 hours after ingestion).

Trial Locations (1)

17012-901

Bauru School of Dentistry/USP, Bauru

All Listed Sponsors
collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

lead

University of Sao Paulo

OTHER

NCT03092193 - Pharmacogenetic and Pharmacokinetics of Naproxen and Associated Naproxen-esomeprazole | Biotech Hunter | Biotech Hunter