RPCEC00000039
Completed
Phase 1
Pharmacokinetics and pharmacodynamics comparison of two pegylated interferon alpha-2 formulations in healthy volunteers.
Center for Genetic Engineering and Biotechnology (CIGB)0 sites16 target enrollmentOctober 7, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- one. Healthy volunteers.
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Enrollment
- 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Absence of antecedents from chronic diseases. 2\. Absence of antecedents from acute diseases in the last 30 days. 3\. Absence of symptoms and signs with the physical examination and laboratory test. 4\. Seronegatives for HIV, hepatitis B and hepatitis C tests. 5\. Voluntariness of the individual through the signing of the informed consent. 6\.18\-35 years of age. 7\. Quetelet Index (19\-29\), (weight in kg, height in square meter). 8\. Male.
Exclusion Criteria
- •1\. Personal pathological antecedents from chronic diseases. 2\. Individuals who have undergone treatment with some type of interferon in the last 30 days. 3\. To refer some acute viral disease in the last 30 days. 4\. To be under medication that can alter immunity. 5\. Antecedents of allergy, idiosyncracy or hypersensitivity to a drug. 6\. Surgery during the 6 previous months to the study initiation. 7\. Blood donation three months before the study initiation. 8\. Antecedents of alcoholism.
Outcomes
Primary Outcomes
Not specified
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