Dear Praful i dont think it is possible because both IR and MR have completely different release pattern and hence BE parameter  like AUC , Cmax, Tmax will be different.

You can also refer the US FDA guidelines for same.

Dear Pravin, Thank you for reply.

Dear Praful,

If the MR product is newly developed by you only and you don't have any comparator. Then you can do the comparison. But as I understand we will call this study a bio-availability study not bioequivalence study. Also your MR product should have same AUC, prolonged Tmax and cmax smaller than the IR product in order to prove that you have successfully created the MR formulation. You will find the literature regarding this for more details.

Dear Naidu Thank you,

MR formulation is first time developed only IR available in market. so...

Is there any possibility to compare IR test and MR test Vs IR ref. in single study.. any possibility...?  

It is newly developed then what could be design of study. I am searching literature but not able to find relevant.

Kindly give your suggestion.

Dear Praful, Please read this article. May be you find this useful.

Pharmacokinetic comparison of sustained- and immediate-release oral formulations of cilostazol in healthy Korean subjects: a randomized, open-label, 3-part, sequential, 2-period, crossover, single-dose, food-effect, and multiple-dose study.

Lee D1, Lim LA, Jang SB, Lee YJ, Chung JY, Choi JR, Kim K, Park JW, Yoon H, Lee J, Park MS, Park K.

http://www.ncbi.nlm.nih.gov/pubmed/22129569

Dear Naidu, Thank you very much.

In this study they have divide in part but, I want to know that can we do direct 3-way study (T1-IR test, T2-MR test Vs R-IR ref.).

Yes you can always run a pilot study of this design. But for the main approval studies I am not sure.Is your test IR  bio-equivalent to Ref IR? 

Thanks naidu,

Test and ref. both formulations are IR.

Direct want to do multiple dose study (No single dose study).

reference formulation is recommended for three time daily. So I want to evaluate Bio. by IR test Vs. IR ref three time a day. Is it possible....and what about regulatory...thy will accept such kind of results.

I will suggest you to see previous MR formulation approvals (EMA or USFDA). You can also check clinicaltrials.gov site for ongoing and completed projects.

New ER formulation comparison to an already-approved IR product

 For drugs with linear pharmacokinetics over the therapeutic dose range: A fasting study should be conducted comparing the ER product administered as a single  dose at the highest strength to the IR reference administered over the least  common time interval to achieve equivalent total dose as for the ER product. for safety reasons the highest strength cannot be used, a lower strength may be  acceptable.

For drugs with nonlinear pharmacokinetics over the therapeutic dose range: At a minimum, a single dose of the highest and lowest strengths of the ER product  should be compared to their corresponding IR references administered over the  ER dosing interval. If the relative BA of intermediate ER strengths cannot be  inferred based on the above studies, a single-dose fasting study for the  intermediate strength(s) of the ER product should be compared to the  corresponding IR reference administered over the ER dosing interval.

Please find below link for receantly published article

Is it possible to achieve bio-equivalence between an oral solid immediate-release and an analogue enteric-coated formulation?Journal of Pharmacy and Pharmacology

Dannit Licht, Rachel Cohen, Ofer Spiegelstein, Laura Rabinovich-Guilatt, Marina Zholkovsky, Adrian Gilbert, Jennifer B. Dressman and Muhammad Safadi

Version of Record online : 27 JUL 2016, DOI: 10.1111/jphp.12597