The montelukast sodium OSF (5 mg/piece; lot No. 18L0011Q11, expiration date: 7 November 2020), manufactured and provided by Qilu Pharmaceutical Co., Ltd., and the reference montelukast sodium CT (5 mg/tablet; lot No. N032451; expiration date: 26 September 2019), marketed under the brand name Singulair® (Merck Sharp & Dohme Ltd., Kenilworth, NJ, USA), were used for the bioequivalence assessment.
Healthy adult males and females aged 18 years or older, weighing at least 50 kg for males and 45 kg for females, and with a body mass index between 18.6–28.5 kg/m2 (both inclusive), were eligible for inclusion. Volunteers were assessed by a comprehensive medical examination, including allergic history, medical history, smoking history, physical examination, vital signs (blood pressure, pulse rate, and temperature), laboratory tests [hematology, chemistry, coagulation function, urinalysis, human immunodeficiency virus, hepatitis B and C, syphilis diagnostic profile, and serum pregnancy test (females only), urine screening to test for drug abuse, alcohol breath testing], and 12-lead electrocardiography (ECG).
Volunteers with any history or evidence of the following were excluded: hypersensitivity to montelukast or any other components of the study drugs or their analogs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs; had clinically relevant diseases, drug or alcohol abuse, or excessive smoking. Furthermore, female volunteers who were pregnant, breastfeeding, or likely to become pregnant within 3 months were also excluded.
Healthy adult males and females aged 18 years or older, weighing at least 50 kg for males and 45 kg for females, and with a body mass index between 18.6–28.5 kg/m2 (both inclusive), were eligible for inclusion. Volunteers were assessed by a comprehensive medical examination, including allergic history, medical history, smoking history, physical examination, vital signs (blood pressure, pulse rate, and temperature), laboratory tests [hematology, chemistry, coagulation function, urinalysis, human immunodeficiency virus, hepatitis B and C, syphilis diagnostic profile, and serum pregnancy test (females only), urine screening to test for drug abuse, alcohol breath testing], and 12-lead electrocardiography (ECG).
Volunteers with any history or evidence of the following were excluded: hypersensitivity to montelukast or any other components of the study drugs or their analogs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs; had clinically relevant diseases, drug or alcohol abuse, or excessive smoking. Furthermore, female volunteers who were pregnant, breastfeeding, or likely to become pregnant within 3 months were also excluded.
