Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency

Exclusion Criteria

• •A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• •A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product.
• •Subjects who (for whatever reason) have been on an abnormal diet during the four weeks preceding the study.
• •Subjects who donated blood within 30 days or plasma within 14 days of the first study dosing.
• •Participation in a clinical trial within 30 days prior to study initiation.
• •Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior to or during the study.
• •Use of any prescription medication within 14 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential.
• •Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to or during the study.
• •Smoking or use of tobacco products within 6 months prior to or during the study.
• •Female subjects who are trying to conceive, are pregnant, or are lactating.
• •Positive serum pregnancy test at screening or urine pregnancy test prior to each drug administration for all women regardless of childbearing potential.
• •Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse.