Clinical Research ::

This department focuses on clinical pharmacokinetics, Phase III and IV clinical studies, bio-equivalence studies for generic drugs.

The Unit has two independent functions namely :

• Planning & execution of Phase- 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. 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.

New Products Selection & Development in :

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

Studies :

• Phase 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 :

Major functions :

The distinct function of the unit is:

• Comparative Bio-availability Studies for Known Molecular Entities

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