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Frontage Completes Phase I Botanical Drug Study

Marks step in the sponsor’s path for FDA approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Frontage Laboratories, Inc. has completed a Phase I study for a client in China. The trial was conducted at the Frontage Clinical Center in Hackensack, NJ and examined the safety and tolerability of a botanical/plant-derived agent in softgel capsules. This Phase I study marks a significant step for the sponsor’s path toward U.S. FDA approval. The trial enrolled 30 healthy volunteers in an open-label, single-dose, dose-escalation study. According to the study sponsor, it was completed with “high...

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