S.I'M.ndall's

Phone: - 2407 8300 - Fax: 91-022-24078879Website: www.tdmlab.com

E-mail: tdmlab@vsnl.net

PROTOCOL NUMBER: L (:i 080<1''2.5 - 0\

THERAPEUTIC DRUGMONITORINGLABORATORY

..~~~~-~-~---- -- •• - r

INSTITUTIONAL ETHICS REVIEW COMMITIEEAPPROVAL LETTER

Date: '24 /R /2008.

ToTHE THERAPEUTIC DRUG MONITORING LABORATORY194,scheme No.6, Road No. 15,Sion-Koliwada, Sion (East),Mumbai - 400 022, INDIA

Subject:A·~

Approval to conduct G9mparati~ Bioavailability I Bioequivalence studies on

Dear Sir,

This is with reference to yoUr above-mentioned proposal to conduct BE studies on healthy human

volunteers. The rremters of the Ethics Review Committee hereby approve the conduct of BE study on

healthy human volunteers under the foUowing conditions:

1. The study will follow the normal protocol of two periods, two sequences, two treatments,

randomized crossover design with necessary food and fluid control.

2, The maximum volume of blood withdrawn from each volunteer in a 24 HR. period will not

exceed 150 mL

3. Validated Method will be used for the analysis.

4. This approval is valid for a period of six months from the date of approval by IRB or six

months from the date of the protocol approval by the concerned drug regulating authorities,

which ever is later.

5. Any change in the protocol must be done only with the consent of IRB.

6. The study should be conducted in ace a ce within the guidelines of ICMR and Helsinki.

PAGE 001 OF 003APPROVAL LETTER

296W.~:s!t~~~t.:~ 194, Scheme No 6, Road No 15, Sion Koliwada, Sion (E), Mumbai 400 022

t •

M THERAPEUTIC DRUGMONITORINGLABORATORY

194, Scheme No.6, Road N;Sion Koliwada, Sion (E), Mumbai 400 0Phone: • 2407 SJOO • Fax: 91-022-2407SS

• E-mail: tdmlab@vsnl.r

PROTOCOLNUMBER: LAo 80915" - 0 \

1. Drug Name LAHJT \01 Nt

2. Dosage Form ~,\..(Y) COATED jf11SLET -i3 I Dose I \Omj--4 Wash Out Period '5 OA'1'S

--5. Sampling Hours 0·00 0·25 0.5""0 0.75 \·00 V~.5 \·§O VIS '2·00 2·g)

3-00 3-50 Lj.oc> 5".00 6·00 8·.~O \0..00 \'L-De 16·00 18·002.~·oo - - - - - - .- -.-

Sincerely,Ethics Review CommitteeTherapeutic Drug Monitoring Laboratory, SIONMembers of Institutional Ethics Review Committee,

Sr.No. Name of the Person Designation Signature--

1. Dr. Savita Sahani Chairperson h~·._- ----2. Dr. Prashant Kulkarni Medical Director J-I L y<---' ,..Jr--3. Dr. Rohan Jadhav Mecfical Director ~.

4. Dr. Jagdish Keny Asst. Medical Directorr. -------

-11//v

5. Dr. Kiran Keny Physician Kr (\,6_ Dr. Arllkurnar Chopade Medical Professional ~t-.7. Mr. Jayprakash Sawant Lawyer "'~,~\

II8. Dr. Dipak Vora E<iJcationalist r-oc> --------9. Mrs. PRi:Jha Tirtnare Social Wor1<er --~~.10. Dr. Kiran Mangaonkar Social Worker & Educationalist ~V-11. Ms_ Kamna N.K_ Marwah - Nutritionist ~~\,--12. Ms. Ranjana Todankar Lawyer ~r-13. Mr. Shrikan! Govilkar L~ / dson~

~

I~-" ~

APPROVAL LETTER /' PAGE 002 OF 003

)297

194, Scheme No.6, Road NilSion Koliwada, Sion (E), Mumbai 400 rPhune: • 2407 IBOO • Fa~ : 91-022-2407Ilh

• E-mail: tdmlab@vsnl.p

M. THERAPEUTIC DRUGMONITORINGLABORATORY ----_ ...- -.

PROTOCOL NUMBER'

14. Mr. Elvis Thomas Social WO!1<eI'~

15. Dr. Manjari Mvani PharmacolOgist .f\b~--

~€. Mr. Krislmakant Pawa- layman~.... --- ..

•1 Dr.Sudhir Memekar , Dermatologist JyY.J~..-II.

. ~',0, '. \

APPROVAL LETTER PAGE 003 OF 003

29