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SAFETY & CLINICAL DEVELOPMENT
Clinical & Experimental Medicine
CLINICAL TRIAL DOCUMENTS

Centperazine (Anti-filarial): Summary of Phase I clinical pharmacological data on (3 ethyl 8 methyl 1, 3, 8 triazo bicyclo (4, 10) decan 2 one, Centperazine .Vol. 2, 1976.

Centazolone (Tranquillo-Sedative): Summary of Phase II clinical pharmacological data on 3- amino-benzo-(6, 7)-quinozoline-4-one, Centazolone .Vol. 3, 1976.
Centbutindole (Neuroleptic): Summary of Phase I clinical pharmacological data on 2-r- p-fluorobenzoyl propyl 1, 2, 3, 4, 6, 7, 12, 12A, octahydropyrazino (2', 1': 6, 1 pyrido (3, 4) indole, Centbutindole .Vol. 3, 1977.
Centpropazine (Anti-depressant): Summary of Phase I clinical pharmacology data on 1(p- propionyl phenoxy) 3-(N-phenyl piperazinyl) propan-2-OL, Centpropazine.Vol.2, 1977.
Gugulipid (Hypolipidaemic): Summary of clinical pharmacology data on Gugulipid (Phase I study) .Vol.2, (1978).
Gugulipid (Hypolipidaemic): Summary of clinical pharmacology data on Gugulipid (Phase II study) .Vol. 3, (1981).
Mefloquine (Anti-malarial): Summary of Phase I clinical pharmacology data on mefloquine.Vol.2, (1983).
Mefloquine Combination (Anti-malarial): Summary of preclinical, toxicological, pharmacological and clinical pharmacological data on Mefloquine, Pyrimethamine and Sulphadoxine combination (1984).
Centbutindole (Neuroleptic): Phase III clinical data and summary of preclinical, Phase I & II clinical data (1986).

Gugulipid (Hypolipidaemic): Phase III clinical data and summary of preclinical & Phase I & II clinical data revised (1986).

Chandonium Iodide (Neuromuscular blocking agent): Phase I/II clinical data & preclinical data (1987).
Centchroman (Anti-breast cancer): Summary of preclinical data, plan and results of Phase II trial and plan for Phase III clinical trial (1988).
Centpropazine (Anti-depressant): Phase II clinical data (1989).
ab Arteether (Blood schizontocidal anti-malarial): Summary of preclinical data, plan and results of Phase I clinical trial and plan for Phase II clinical trial (1992).
CDRI Compound 80/53 (Anti-relapse anti-malarial): Summary of preclinical data, plan and results of Phase I clinical trial and plan for Phase II clinical study (1992).
Picroliv (A hepatoprotective agent): Summary of preclinical data, plan and results of Phase I clinical study and plan for Phase II clinical trial (1992).
CDRI Compound 80/574 (A hypolipidaemic agent): Summary of preclinical data, plan and results of Phase I clinical trial and plan for Phase II clinical study (1992).
Chandonium Iodide (A neuromuscular blocking agent): Summary of preclinical data, plan and results of Phase I/II and III clinical trial (1993).
CDRI Compound 73/602 (An anti-allergic agent): Summary of preclinical and plan and results of Phase I clinical trial and plan for Phase II clinical study (1993).
Consap (A spermicidal agent; contraceptive cream): Summary of preclinical data, results of Phase II clinical trial and plan for Phase III clinical trial (1993).
Arteether (A new blood schizontocidal anti-malarial): Summary of preclinical, Phase I clinical data, plan and results of Phase II clinical studies, plan for Phase III clinical trial (1994).
Centpropazine (A new anti-depressant): Summary of preclinical Phase I, II clinical data and results of Phase III clinical trial (1995).
CDRI Compound 81/470 (Anti-helminthic agent) Summary of preclinical data, plan and results of Phase I clinical trial, plan for Phase II clinical study (1996).
Arteether (A new blood schizontocidal anti-malarial): Summary of preclinical, Phase I, Phase II clinical data and plan and results of Phase III multicentric clinical trials. (1996)
Bacoside A&B (Memory Enhancer): Summary of preclinical data, plan and results of Phase I clinical trial, plan for Phase II clinical study (1997).
CDRI Compound 80/53 (Anti-relapse anti-malarial): Summary of preclinical, Phase I clinical data, plan and results of Phase II/III clinical study (1997).
Memory plus (Nootropic agent): Summary of preclinical data and plan & results of clinical studies (1999).
Arteether (A new blood schizontocidal anti-malarial drug): Phase IV post marketing surveillance data (1999).
Picroliv (Hepatoprotective agent): Summary of preclinical, Phase I clinical study and plan and results of Phase II multicentric clinical trial with plan for Phase III clinical trial (2000).
CDRI Compound 80/574 (Hypolipidaemic agent): Summary of preclinical & Phase I clinical study and plan, results of Phase II clinical trial with plan of Phase III clinical trial (2000).
Arteether (A new blood schizontocidal anti-malarial drug): Summary of preclinical, Phase I, II & III clinical trials in uncomplicated & complicated P.falciparum malaria with plan and results of clinical trial in pediatric patients (2000).
Consap Cream (Contraceptive agent): Summary of preclinical, Phase I & Phase II study with plan and results of Phase III multicentric trials (2001).
CDRI Product: CT-1 (Anti-hyperglycaemic agent): Regulatory pharmacology, safety evaluation, summary of exploratory clinical study and protocol for Phase I/II clinical trial in patients of Type-2 Diabetes mellitus. (Aug. 2002).
betes mellitus patients (Aug. 2002).
CDRI PRODUCT CT-1 (Anti-hyperglycaemic agent) Protocol for Phase II clinical trial in patients of Type 2 Dia
CDRI PRODUCT: CDR 134-D123 (Anti-hyperglycaemic agent) Vol. 1 - Preclinical data containing chemical and pharmacological profiles, results of experimental studies for efficacy evaluation and 3 months toxicity studies in rats & monkeys (Jan. 2003).
CDRI PRODUCT: CDR 134-D123 (Anti-hyperglycaemic agent) Vol. 2 - Protocol for Phase I clinical trial and case record forms (Jan. 2003).
Comp. 97/78 (Anti-malarial agent) Protocol for Phase I clinical trial and case record forms (Sept. 2006).
CU-1/002 preparation for management of hyperlipidemia - Application for permission to undertake Phase I clinical trial (Feb. 2007).
CDRI PRODUCT CT-1 (Anti-hyperglycaemic agent) - Summary of chemical pharmacological, toxicological and clinical data (Oct. 2008).
CDRI Comp.99/373 - Investigators Brochure (July 2009)
CDR 134-F194 (Anti-hyperglycaemic agent) IND application for Phase I clinical trial (Vol. I & II) (Aug. 2007).
Comp.99/373 (Anti-osteoporotic agent) - IND application for Phase I clinical trial (Vol. I & II) - Aug. 2007
a,ß Arteether (A new blood schizontocidal anti-malarial): Summary of preclinical, Phase I, Phase II, Phase III clinical trials with plan and results of clinical trials in pediatrics patients (March 2008)
CDR 134-D123 - Product profile
CDR 134-F194 - Investigators Brochure (May 2009)
CDR 134-F194 (Anti-hyperglycaemic agent) IND application for Phase I clinical trial (Vol. I & II) - Modified version (Aug. 2009).
 
 
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