A randomized, open-label, single dose, two-way crossover bioequivalence study of Erythropoietin-SBS 4000 IU subcutaneous injection relative to Hema-Plus 4000 in healthy Thai volunteers
- Conditions
- Healthy Thai volunteersHealthy volunteers
- Registration Number
- TCTR20210511002
- Lead Sponsor
- Siam Bioscience Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 24
1.Healthy Thai subjects are between 18 to 55 years of age
2.The Body Mass Index (BMI) ranges from 18.5 to 30 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 within past 1 year)
5.No history of alcoholism (more than 2 years)
6.Negative pregnancy test for women and no breast-feeding
1.History or evidence of allergy or hypersensitivity to Epoetin alfa or product derived from mammalian cells or human albumin or any related drugs or any of the excipients of this product
2.Subject with BP is Systolic BP below 85, from 130 mm/Hg and over; Diastolic BP below 60, from 90 mm/Hg and over; Pulse rate over 100 bpm
3.Serum bilirubin greater than 1.5 times ULRR
4.Serum creatinine greater than 1.5 times ULRR
5.Alanine amino transferase or aspartate amino transferase greater than 2 times ULRR
6.Positive of hepatitis B or C virus
7.Have more than one abnormal EKG, which is considered as clinically significant
8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma, thrombotic vascular events, cerebrovascular accidents
9.History of epilepsy or seizures
10.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy
11.Any major illness in the past 3 months or any significant ongoing chronic medical illness
12.History of psychiatric disorder
13.History of regular alcohol consumption and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study
14.History of usually smoking, if moderate smokers cannot stop at least 7 days before the study drug administration and until the completion of each period of the study
15.High caffeine consumption and cannot stop at least 2 days before the study drug administration until the completion of each period of the study
16.Positive drug abused test in urine
17.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer)
18.History of difficulty in accessibility of veins in left and right arm
19.Blood donation within the past 3 months before the study
20.Participation in any clinical study within the past 3 months before the study
21.Subjects who are unwilling or unable to comply with this protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax and AUC0-72 pre-dose (0.00 hour) and at 1.0, 3.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 14.0, 16.0, 24.0, 48.0 and 72.0 hours after dosing Erythropoietin plasma concentration by ELISA
- Secondary Outcome Measures
Name Time Method Tmax, Half-life, Kel, ratio AUC0-t and AUC0-infinity pre-dose (0.00 hour) and at 1.0, 3.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 14.0, 16.0, 24.0, 48.0 and 72.0 hours after dosing Erythropoietin plasma concentration by ELISA,Safety The subjects will be monitored for adverse events throughout the entire confinement periods and all AEs reported by the subjects or observed by the investigators Adverse events