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:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual ... in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon ... fun run is geared towards children of all ages; it is a non-competitive, non-timed ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare ... program management, will showcase a range of technology and learning solutions at the ... Convention and Expo to be held October 14–18, 2017 at the Mandalay Bay ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... CHICAGO , Sept. 28, 2017 Hill-Rom ... quarter 2017 earnings conference call and webcast on Friday, ... 8:00 a.m. (EDT) and ending at approximately 8:30 a.m. ... to discussing the company,s 2017 financial performance and guidance ... growth opportunities, initiatives to enhance operational performance, and long-range ...
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: ... data solutions, today announced that its MyDario product is expected to appear ... listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, The ... ...
(Date:9/23/2017)... HORSHAM, Pa. , Sept. 22, 2017 ... received a complete response letter from the U.S. Food ... (BLA) seeking approval of sirukumab for the treatment of ... response letter indicates additional clinical data are needed to ... of moderately to severely active RA. ...
Breaking Medicine Technology: