Oral Bioavailability and Pharmacokinetics of Nonanimal Chondroitin Sulfate and Its Constituents in Healthy Male Volunteers

Volpi N, Mantovani V, Galeotti F, Bianchi D, Straniero V, Valoti E, Miraglia N · Clinical Pharmacology in Drug Development

A biofermentative preparation produced plasma concentrations roughly 44% higher than the animal-derived comparator, with the gap holding at 48 hours, measured as total chondroitin sulfate and the compositional disaccharides. Tolerability was reported as excellent. The practical point for anyone reading the trial literature is that preparation changes exposure by a large margin at the same nominal dose.

Population

Healthy male volunteers, 48-hour pharmacokinetic follow-up

Intervention

Single 2,400 mg dose of nonanimal (biofermentative) chondroitin sulfate

Comparator

Animal-derived chondroitin sulfate

Limitations

Single dose, healthy volunteers, no joint endpoint. Several authors are affiliated with the manufacturer of the nonanimal preparation being favoured, and the comparison is against an unnamed animal-derived product. Inherits the exogenous-versus-endogenous measurement problem that divides this literature.