PHARMACOKINETIC STUDY OF ALENDRONATE PLUS CALCITRIOL (MAXMARVIL) IN KOREAN HEALTHY POSTMENOPAUSAL WOMEN

Yoon-Sok Chung, Yong Jun Choi, So-Yeon An, Min-Suk Lee

Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea

Abstract:

Introduction: Maxmarvil is enteric coated alendronate and calcitriol combination tablet to enhance the gastrointestinal absorption rate and decrease gastrointestinal side effects. We performed pharmacokinetic study of Maxmarvil in Korean.

Methods: Total 18 subjects of 55 years or older healthy Korean postmenopausal women without previous history of fracture or bisphosphonate medication had been studied. An open-label single oral administration of alendronate 5 mg plus calcitriol 0.5 µg (Maxmarvil) had been tested. Three collections of urine with timed intervals (0~6 hours, 6~12 hours, 12~24 hours) were collected for 24 hours. Alendronate was measured by HPLC-FLD method (Bio-Medieng, Korea). The Aet, Umax, Tmax were calculated. Baseline and follow-up of medical history, physical examination, and laboratory tests were evaluated for safety. Statistical analysis of one-sample paired t-test was performed.

Results: The alendronate Aet was 21.63 ±14.92 µg, Umax was 2.91 ±1.77 µg/hr, and Tmax was 6.67 ±1.94 hr, respectively. Mild grade of adverse events were occurred in three subjects (16.7%) including one case of upper gastrointestinal discomfort and two cases of myalgia.

Conclusion: Urinary excretion of Maxmarvil for 24 hours was 0.43%. There was no serious adverse event in Korean postmenopausal women.