Navigation Links
Charleston Laboratories, Inc. Phase I Clinical Trial
Date:1/12/2009

Charleston begins Bioequivalence Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CL-108

CHARLESTON, S.C., Jan. 12 /PRNewswire/ -- Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced today the initiation of a pharmacokinetic study on its first drug candidate, CL-108. "After many months' development in the lab, resulting in the optimal formulation of this drug, it is ready for testing in man," said Dr. Bernard Schachtel, Chief Medical Officer at Charleston Laboratories. "This Phase I study is being conducted to identify and characterize the release characteristics of CL-108, showing its differences (and similarities) to comparator drugs. We expect that the in-vivo results from this study will confirm the in-vitro results on CL-108, which can be advanced to the Phase III efficacy and safety trial we discussed with the FDA at our Pre-IND Meeting."

In fact, Dr. Schachtel added, "When the results of the Phase I study are available (in early 2009), Charleston Labs will be ready to test the efficacy and safety of CL-108 in patients with acute pain. Charleston Labs' Phase III study on CL-108 is already in the planning stages," he said. "Clinical investigators have been selected at major U.S. universities to conduct this large study beginning in 2009."

"We are looking forward to achieving the expected results of our fast dissolving low dose anti-emetic," said Paul Bosse, Chief Executive Officer at Charleston Laboratories. "CL-108 is the first of many planned therapeutic products Charleston is advancing into clinical studies." Reaching this exciting milestone is a testament of perseverance and dedication by the entire Charleston team."

All clinical studies for Charleston Laboratories are being overseen by SRC, Inc., a contract research organization based in Jupiter, Florida that is renowned for its clinical trials on patients' symptoms (such as nausea and vomiting) and its record of drug approvals by regulatory authorities in the U.S. and worldwide.

About Charleston Laboratories, Inc.

Charleston Laboratories Inc, headquartered in Charleston, SC, is a privately funded specialty pharmaceutical company developing and commercializing opioid drugs with minimal or no opioid-induced nausea and vomiting (OINV). Charleston Laboratories intends to enter into discovery and commercialization alliances with partners motivated to introduce novel pain therapies that eliminate or significantly reduce nausea and vomiting.


'/>"/>
SOURCE Charleston Laboratories, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Doug Flutie, Jr. Foundation Grants NAA $10,000 for Burbacher/Charleston Study
2. The Hope Clinic in Charleston, SC invests in technology to prevent vision loss in patients
3. Charleston, S.C., Market Integration Likely to Drive Physician Groups to Seek Health System Affiliation
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
6. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
7. Forest Laboratories, Inc. Sets Date and Conference Call for Fiscal 2008 Second Quarter Earnings
8. Roxane Laboratories, Inc. Announces the Launch of Oxcarbazepine Tablets, 150mg, 300mg and 600mg
9. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
10. Getting Ready Corporation and Winston Laboratories, Inc. Announce Merger Agreement
11. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lexapro(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/7/2016)... Texas (PRWEB) , ... February 07, 2016 , ... ... new MyDecision™ program. MyDecision™ empowers employers and organizations with the tools and information ... MyDecision™ combines three elements to cut the cost of providing employee healthcare benefits ...
(Date:2/6/2016)... ... February 06, 2016 , ... ... ADVISORY: 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , ... the world with an estimated 5000 perioperative nurses in attendance to study ...
(Date:2/6/2016)... ... ... With the FCPX LUT: Summer pack from Pixel Film Studios, ... is a Lookup Table that contains a mathematical formula for modifying an image. The ... manipulating each pixel, LUT's can change each color range differently, it gives the user ...
(Date:2/6/2016)... , ... February 06, 2016 , ... ... of eating disorder treatment helps to reduce the frequency and level of relapse. ... Recovery Phase: Re-Establishing Healthy Identity and Purpose,” will explore the critical tasks of ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the air ... variety of colors, assortments and packaging. This staple for Valentine’s Day is a must-have, ... , For Valentine’s Day, not only are long-stem roses available, but also other ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... 4, 2016  Omnicell, Inc. (NASDAQ: OMCL ), a ... healthcare systems, today announced results for its fiscal year ... --> --> GAAP results: Revenue for ... $5.1 million or 4.1% from the third quarter of ... fourth quarter of 2014. Revenue for the year ended ...
(Date:2/4/2016)... 2016  Aethlon Medical, Inc. (Nasdaq: AEMD ... to treat life-threatening diseases, today announced results for ... 31, 2015. --> ... in our last quarterly call, we strategically advanced ... objective to establish the Aethlon Hemopurifier® as a ...
(Date:2/4/2016)... 4, 2016  AMRI (NASDAQ:  AMRI) today announced that ... and President of Pfizer Global Supply, has been elected to ... 2016. In addition, the Company announced that Mr. Gabe ... since 2010, has retired from the AMRI Board of Directors ... other business ventures.  William S. Marth , ...
Breaking Medicine Technology: