Clinical Research ::

This department focuses on clinical pharmacokinetics, Phase I and Phase II clinical trials on Investigational New Drugs - INDs, Phase III and IV clinical studies, bio-equivalence studies for generic drugs.

The Unit has two independent functions namely :

• Planning & execution of Phase-I, II, III & IV studies,
• Clinical pharmacokinetic studies.

Major Functions :

Marketing of a new drug in India, requires a Clinical trial in an appropriate patients population to establish safety & efficacy and Bio-equivalence study; comparing the bio-availability of test formulation with reference i.e. innovator's formulation in healthy volunteers.

The unit identifies unmet medical needs and strives to find out a suitable intervention; be it a drug formulation or a device. Presently, regulatory activities for filing for domestic market dominate majority of the work. This comprises of Phase III & Phase IV Clinical trials. In the changing global scenario and in conformation with the goals of TRC, the unit contributes in a multidisciplinary team for drug discovery. Investigators Brochure and trial protocol as per ICH guidelines, are prepared for clinical trials to be carried out in India or internationally. Clinical Research being the last portal for a drug going to the regulatory authorities and ultimately to the market, reviews all the evidences for its safety and efficacy, before submission.

The unit liaises with regulatory authorities i.e. Drugs Controller General (India) for necessary test license and permissions for carrying out clinical trial and for obtaining manufacturing & marketing permission for a new drug.

The unit has requisite capabilities to plan for, conduct of and analyzing the results of the clinical studies carried out in collaboration with various prestigious Medical Institutes all over India.

With a view to keep in touch with the medical professionals for unmet medical needs, the Unit also liaises with eminent professionals in the TRC's present thrust areas i.e. Diabetes, Coronary Artery Disease, Tuberculosis and Organ Salvage after Ischaemic Damage.

New Products Selection & Development in :

• Liaison with Marketing Division
• Liaison internally with R&D Divisions
• Liaison with Collaborators

Studies :

• Phase I, II, III & Phase IV Clinical Trials

Regulatory Affairs :

• Pre-Marketing / Marketing / Post Marketing

Training / Promotional Activities :

• Field Staff Training / Clinical Symposia / Work Shop / Panel Discussions

Achievements :

As a part of Domestic / International Regulatory requirements, Clinical Research has conducted clinical trials of several molecules including Nocorandil, Repaglinide, Rosiglitazone, Clopidogrel & Sildenafil in the recent past.

The following are some of the recent introductions :

Clinical Pharmacokinetics :

One of the critical aspects in the process of a "chemical" becoming a "drug" is thorough understanding its kinetics i.e. the processes it passes through once administered in the body until the time it is excreted out. It is thus, study of absorption, distribution, metabolism and excretion of a drug.

Major inputs for this come from animal kinetics studies carried out during the pre-clinical development.

The process of planning for pharmacokinetics studies for New Chemical Entities (NCE) starts with identification of lead compound. Pharmacological / Toxicological evaluations have built in parameters for study of animal pharmacokinetics. This help in finalizing the dose range for Phase-I studies. Thus, the actual studies start much later in the process of drug development, the data generated all through help in defining the kinetic parameters the formulation must achieve.

Clinical Pharmacokinetics carries out human pharmacokinetic studies on generic drugs in conformity with GCP/GLP guidelines, both for domestic as well as international regulatory requirements. Apart from requirements of regulatory submission, kinetic studies in smaller number of volunteers, is carried out as an on going activity for confirming the bio-availability of a new formulation.

Major functions :

The unit has two distinct functions viz.:

• Comparative Bio-availability Studies for Known Molecular Entities
• Bio-availability Studies for New Chemical Entities (NCE)

Achievements :

Since the time of its inception, the unit has conducted 38 (12 / 24 volunteers) pharmacokinetic studies. In these studies, a comparative bioavailability of Torrent's formulation (Test) was measured against Innovator's brand (Reference). These studies have been used for domestic as well as international regulatory submissions.

Test Formulation (Torrent) :

1. Amlodipine (AMLOC)
2. Amoxicillin (TORMOXIN)
3. Ampicillin (TORCILLIN)
4. Azithromycin (AZITOR)
5. Carbamazepine SR (CARBATOL SR)
6. Carteolol
7. Cefadroxyl Disp (250mg x 2) (DROXYL KID)
8. Cefixime (TOPCEF)
9. Cerivastatin (SERIVA)
10. Cetirizine (ZIRTIN)
11. Ciprofloxacin (QUINTOR)
12. Cisapride (UNIPRIDE)
13. Clopidogrel (DEPLATT)
14. Diclofenac Potassium
15. Diltiazem USP (DELTAZEM 60)
16. Fexofenadine (FEXO 120 - 180)
17. Finasteride
18. Lamotrigine (LAMITOR)
19. Lansoprazole (LANSOTOR)
20. Losartan (TOZAAR)
21. Mefloquine
22. Mosapride (MOSID MT 2.5 & 5)
23. Moxifloxacin (MOXIF 400)
24. Nicorandil (NIKORAN)
25. Nimodipine (NIMOTIDE)
26. Pefloxacin (PEFCIN)
27. Repaglinide (EUREPA)
28. Risperidone (RESPIDON)
29. Rosiglitazone (ENSELIN)
30. Sertraline (SERENATA)
31. Sibutramine (SLENFIG)
32. Sildenafil (ANDROZ)
33. Sodium Valproate + Valp. Acid (VALPARIN SR)
34. Sparfloxacin (TOROSPAR)
35. Sultamicillin (BETAMPORAL)
36. Venlafaxine (VENLIFT)
37. Zolpidem