Mumbai, Feb 24 (UNI) Glenmark Pharmaceuticals SA (GPSA) has announced that its lead DPP-IV inhibitor candidate for diabetes, GRC 8200, has successfully completed its Phase I study.
A press release issued here today stated that the study was filed with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and was conducted by Parexel, UK.
Glenmark Pharmaceuticals SA is the wholly-owned Swiss subsidiary of Glenmark Pharmaceuticals Limited.
The objective of the Phase I study was to assess the safety and bio-availability of GRC 8200 in humans and was conducted using single and multiple oral doses on 88 healthy volunteers.
It was found that the compound was very well tolerated by the subjects at all dosage levels and there were no significant adverse events reported, stated the release, adding that the study design included eight single dose regimens with 800 mg as the highest dose.
GRC 8200 has now entered Phase II testing with trials that are beginning in South Africa at a US FDA approved CRO. The company also intends to file a US IND for GRC 8200 by May 2006 for further Phase II clinical testing and expects to complete all Phase II trials by March 2007, stated the release.
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