A Bioequivalence study of a randomized, open-label, single dose, two-way crossover of Filgrastim (Filgrastim/SBS) 300 mcg SC injection relative to Filgrastim (Filgrastim/CIM) 300 mcg SC injection in healthy Thai volunteers

Phase 1

Completed

Conditions: healthy human volunteersneutropenia

Registration Number: TCTR20180321003

Lead Sponsor: Siam Bioscience Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Healthy Thai subjects are between 18 to 55 years of age.
2.The Body Mass Index (BMI) ranges from 18 to 25 kg/m2.
3.Healthy, no history of evidence of chronic disease or severe disorder.
4.No history of usually smoking (more than 10 cigarettes per day).
5.No history of alcoholism (more than 2 years).
6.Negative pregnancy test for women and no breast-feeding.

Exclusion Criteria

1.History or evidence of allergy or hypersensitivity to Filgrastim or E. coli-derived proteins or any related drugs or any of the excipients.
2.Systolic B.P < 90, â‰¥140 mm/Hg, Diastolic B.P < 60, â‰¥90 mm/Hg or pulse rate > 100 beats per minute.
3.Serum bilirubin > 1.5 times the upper limit of reference range (ULRR).*
4.Serum creatinine >1.5 times the upper limit of reference range (ULRR).*
5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) > 2 times the upper limit of reference range (ULRR).*
6.Positive of hepatitis B or C virus.
7.Have more than one significant abnormal EKG.
8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma.
9.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
10.History of psychiatric disorder.
11.History of regular alcohol consumption >7 drinks/week for females or 14 drinks/week for males and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
12.History of usually smoking, if moderate smokers cannot stop at least 7 days before the study drug administration and until the completion of the study.
13.High caffeine consumption and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
14.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids).
15.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-ProveraÂ® must be discontinued at least 6 months) prior to receiving the first dose of study medication.
16.History of difficulty in accessibility of veins in left and right arm.
17.Blood donation within the past 3 months before the study.
18.Participation in any clinical study within the past 3 months before the study.
19.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic end points pre-dose,0.25, 0.50, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48 hr Pharmacokinetic parameters (Cmax, AUC0-t, AUC0â†’âˆž and Tmax, T1/2, Kel, AUC0â†’t/AUC0â†’âˆž)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic end points pre-dose and 0.50, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72, 96, 120 hr Absolute Neutrophil Count (ANC)