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KMID : 0391020120200020135
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2012 Volume.20 No. 2 p.135 ~ p.144
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Comparison of Pharmacokinetics and Safety of Two Formulations of Letrozole (2.5 mg) in Healthy Male Volunteers
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Noh Yook-Hwan
Bae Kyun-Seop
Cho Sang-Heon
Choe Sang-Min
Ghim Jong-Lyul
Jung Jin-Ah
Kim Un-Jib
Jin Seok-Joon
Park Hyun-Jeong
Kim Jung-Chul
Lim Hyeong-Seok
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Abstract
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Background: Letrozole is an oral non-steroidal inhibitor of the aromatase enzyme, which has proven to be a useful drug against breast cancer.
Methods: This single-dose, randomized 2 × 2 crossover study was conducted in healthy male volunteers. Participants of each sequence group (each 13 volunteers for sequence group) received, in randomized sequence, a single oral 2.5-mg dose of generic letrozole (test) or branded letrozole (reference). Each treatment period was separated by a 5-week washout period. Blood samples were collected for up to 312 hours after drug administration, and drug concentrations were determined using validated LC/MS-MS. Pharmacokinetic properties were obtained using noncompartmental analysis. Drug tolerability was assessed throughout the study, using measurements of vital signs, physical examination, clinical chemistry testing, EKG, and interviews.
Results: A total of 26 subjects completed the study. The geometric mean ratios (90% CI) of Cmax and AUClast were 0.92 (0.85 ? 0.99) and 1.01 (0.97 ? 1.04), respectively. No serious AEs were reported, and there were no clinically significant differences between test and reference groups.
Conclusion: The findings from this study suggest bioequivalence between two formulations of letrozole in healthy male volunteers. The safety profile of two formulations had similar characteristics.
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KEYWORD
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Letrozole, Pharmacokinetics, Safety, Bioequivalence, Healthy volunteers
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