% Change of Emtricitabine Co-Administered Dose of Emtricitabine N Pharmacokinetic Drug Dose (mg) Parameters 2 (90% CI) Drug (mg) Cmax AUC Cmin 20 Tenofovir DF 300 once 200 once 17 ( 12 to x 7 days x 7 days 29) - Indinavir 800 x 1 200 x 1 12 - Famciclovir 500 x 1 200 x 1 12 d4T - 40 x 1 200 x 1 6 Zidovudine 300 BID x 7 200 once daily 27 days x 7 days All interaction studies conducted in healthy volunteers = Increase; = Decrease; = no effect; = not applicable “-“ Table 3 Drug Interactions: Change in Pharmacokinetic Parameters for Co-administered Drug in the Presence of Emtricitabine1 % Change of Co-administered Co-Administered Dose of Emtricitabine N Drug Drug Dose (mg) Pharmacokinetic Drug (mg) Parameters 2 (90% CI) Cmax AUC Cmin Tenofovir DF 300 once daily x 200 once daily 17 7 days x 7 days - Indinavir 800 x 1 200 x 1 12 - Famciclovir 500 x 1 200 x 1 12 d4T - 40 x 1 200 x 1 6 Zidovudine 17 13 300 BID x 7 200 once daily 27 (0 to ( 5 to days x 7 days 38) 20) All interaction studies conducted in healthy volunteers = Increase; = Decrease; = no effect; = not applicable “-“
Co-Administered Drug Dose of Drug (mg) Emtricitabine Dose (mg) N % Change of Emtricitabine Pharmacokinetic Parameters 2 (90% CI) Cmax AUC Cmin Tenofovir DF 300 once x 7 days 200 once x 7 days 17 20 ( 12 to 29) Indinavir 800 x 1 200 x 1 12 - Famciclovir 500 x 1 200 x 1 12 - d4T 40 x 1 200 x 1 6 - Zidovudine 300 BID x 7 days 200 once daily x 7 days 27 All interaction studies conducted in healthy volunteers = Increase; = Decrease; = no effect; “-“ = not applicable Table 3 Drug Interactions: Change in Pharmacokinetic Parameters for Co-administered Drug in the Presence of Emtricitabine1 Co-Administered Drug Dose of Drug (mg) Emtricitabine Dose (mg) N % Change of Co-administered Drug Pharmacokinetic Parameters 2 (90% CI) Cmax AUC Cmin Tenofovir DF 300 once daily x 7 days 200 once daily x 7 days 17 Indinavir 800 x 1 200 x 1 12 - Famciclovir 500 x 1 200 x 1 12 - d4T 40 x 1 200 x 1 6 - Zidovudine 300 BID x 7 days 200 once daily x 7 days 27 17 (0 to 38) 13 ( 5 to 20) All interaction studies conducted in healthy volunteers = Increase; = Decrease; = no effect; “-“ = not applicable
auspar-emtricitabine-140612-pi.docx