Healthy Subjects Clinical Trial
Verified date | January 2018 |
Source | Azidus Brasil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).
Status | Completed |
Enrollment | 128 |
Est. completion date | September 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Agree with all study procedures, sign and date back by their own free will, the IC; - Be between 18 and 50 years, of both sexes; - Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28; - are considered healthy, clinical, psychological and laboratory; - are female, but they have and maintain a safe method of contraception during the study. Exclusion Criteria: - Known hypersensitivity to filgrastim; - Hypersensitivity to products derived from E. coli; - fever or infectious disease in the 07 days preceding the first administration; - Positive serology for hepatitis B or C and HIV; - Prior treatment with CSFs, interleukins and interferons; - Participation in a clinical study in the last 12 months; - Donation or loss of blood in the 03 months preceding the study; - General anesthesia in the 03 months preceding the study; - Provide a history of alcohol abuse, drug or drugs; - Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease; - Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
Brazil | LAL Clinica Pesquisa e Desenvolvimento Ltda | Valinhos | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Azidus Brasil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug. | • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05483998 -
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT02417714 -
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
|
||
Recruiting |
NCT02235012 -
Cognitive Biases Under Ketamine
|
N/A | |
Completed |
NCT04418973 -
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
|
N/A | |
Completed |
NCT05088343 -
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06248801 -
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
|
Phase 1 | |
Terminated |
NCT04068259 -
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03279302 -
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06233162 -
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
|
Phase 1 | |
Recruiting |
NCT04159844 -
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
|
N/A | |
Completed |
NCT06137911 -
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
|
Phase 1 | |
Completed |
NCT04849286 -
Measurement of HTL0016878 in Cerebrospinal Fluid
|
Phase 1 | |
Not yet recruiting |
NCT06233227 -
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
|
Phase 1 | |
Completed |
NCT04096157 -
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
|
Phase 1 | |
Completed |
NCT01200368 -
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
|
Phase 3 | |
Recruiting |
NCT05805033 -
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
|
N/A | |
Completed |
NCT04027803 -
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
|
Phase 1 | |
Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
Completed |
NCT02903095 -
Single Ascending Dose Study of TD-1439 in Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT02341508 -
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
|
Phase 1 |