Kraj: Kanada
Język: angielski
Źródło: Health Canada
NABILONE
APOTEX INC
A04AD11
NABILONE
0.5MG
CAPSULE
NABILONE 0.5MG
ORAL
50
Narcotic (CDSA II)
MISCELLANEOUS ANTIEMETICS
Active ingredient group (AIG) number: 0115009002; AHFS:
APPROVED
2015-05-20
_Page 1 of 22_ PRODUCT MONOGRAPH N APO-NABILONE Nabilone Capsules 0.25 mg, 0.5 mg and 1 mg Antiemetic Apotex Inc. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Preparation: May 15, 2015 Submission Control No: 172451 _Page 2 of 22_ N APO-NABILONE Nabilone Capsules THERAPEUTIC CLASSIFICATION Antiemetic Agent ACTION APO-NABILONE (nabilone) is a synthetic cannabinoid with antiemetic properties which have been found to be of value in the management of some patients with nausea and vomiting associated with cancer chemotherapy. It also has sedative and psychotropic effects. After oral administration, comparable peak plasma levels of nabilone and of its carbinol metabolite were attained within 2 hours. The combined plasma concentrations of nabilone and of its carbinol metabolite accounted for, at most, 10 to 20% of the total radiocarbon concentration in plasma. The plasma half-life of nabilone was approximately 2 hours, while that of the total radiocarbon was of the order of 35 hours. Of the two major possible metabolic pathways, stereo-specific enzymatic reduction and direct enzymatic oxidation, the latter appears to be the more important in man. The drug and its metabolites are eliminated mainly in the feces (approximately 65%) and to a lesser extent in the urine (approximately 20%). The major excretory pathway is the bilary system. CLINICAL TRIALS Comparative Bioavailability Studies A randomized, single dose, 2-way crossover comparative bioavailability study, conducted under fasting conditions, was performed on healthy male and female volunteers. The rate and extent of _Page 3 of 22_ absorption of nabilone was measured and compared following a single oral dose (1 x 1 mg capsules) of Apo-Nabilone 1 mg capsules (Apotex Inc.) and N Cesamet ® (nabilone) 1 mg capsules (Valeant Canada Ltd.). The results obtained from 21 volunteers who completed the study are summarized in the following table. Nabilone (1 x 1 mg) From Measured Data Geometric Mean Arithmetic Mean (CV%) Parameter Test* Reference † Ratio of Geometric Mea Przeczytaj cały dokument