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DANOCRINE (DANAZOL) CAPSULES: PHARMACOKINETICS

Absorption

After oral administration of a 400 mg dose to healthy male volunteers, peak plasma concentrations of danazol are reached between 2 and 8 hours, with a median Tmax value of 4 hours. Steady state conditions are observed following 6 days of twice daily dosing of Danocrine (Danazol) capsules.

Dose Proportionality

Bioavailability studies indicate that blood levels do not increase proportionally with increases in the administered dose.

Single dose administration of Danocrine in healthy female volunteers found that a 4-fold increase in dose produced only a 1.6 and 2.5-fold increase in AUC and a 1.3 and 2.2fold increase in Cmax in the fasted and fed state, respectively. A similar degree of non-dose proportionality was observed at steady state.

Food Effect

Single dose administration of 100 mg and 200 mg capsules of Danazol (Danocrine) to female volunteers showed that both the extent of availability and the maximum plasma concentration increased by 3 to 4 fold, respectively, following a meal ( > 30 grams of fat), when compared to the fasted state. Further, food also delayed mean time to peak concentration of Danocrine by about 30 minutes. Even after multiple dosing under less extreme food/fasting conditions, there remained approximately a 2 to 2.5 fold difference in bioavailability between the fed and fasted states.

Distribution

Danazol is lipophilic and can partition into cell membranes, indicating the likelihood of distribution into deep tissue compartments.

Metabolism and Excretion

Danazol appears to be metabolized and the metabolites are eliminated by renal and fecal pathways. The two primary metabolites excreted in the urine are 2-hydroxymethyl danazol and ethisterone. At least ten different products were identified in feces.

The reported elimination half-life of danazol is variable across studies. The mean half-life of danazol in healthy males is 9.7 h. After 6 months of 200 mg three times a day dosing in endometriosis patients, the half-life of danazol was reported as 23.7 hours.

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