| A. Patient Demographics |
12 males, 12 females |
|
aNon-Smokers |
| Age (30 50 yrs) |
|
bWeight (avg. 60 kg for males, 45 kg for females) |
| Height (avg. 178 cm for males, 160 cm for females) |
|
| B. Medical Histories (for exclusion from study) |
Significant Cardiovascular disease |
| Significant hepatic disease |
| Significant renal disease |
| Significant CNS disease |
| Significant hematological disease |
| Significant gastrointestinal disease |
| Clinically significant illness 4 weeks prior to study entry |
| Alcoholism or drug abuse in previous year before study entry |
| Hypersensitivity or idiosyncratic reaction to HA or other GAG |
| Pregnancy |
| Nursing |
| Inadequate contraception |
|
cPersonality disorders |
| Conditions interfering with drug absorption, distribution, metabolism or excretion |
| Use of enzyme inducing drugs within 30 days of study entry |
| Treatment drugs toxic to major organs within 3 months of study entry |
| Abnormal diet during 4 weeks preceding study |
| Through completion of study, donation of >900 mL of blood over 20 weeks |
| Participation a drug study 4 weeks prior to study entry |
|
| C. Prohibited (for duration of study) |
dMedication (including over-the-counter products) |
| Use of alcohol-containing or xanthine-containing beverages through sample collection |
a Subjects could not have used nicotine within 3 months of study entry.
b Patients were within 15% of their ideal weight (“Table of Desirable Weights of Adults”, Metropolitan Life Insurance Company, 1983).
c Includes disorders that would preclude informed consent or compliance with protocol requirements.
d If medication other than that specified in the protocol was required, decision to continue subject was made by L.A.B. Medical Personnel.