Bioequivalence and Bioavailability Forum

Hello All,

Greetings!!

We want to know how to conduct a bioequivalence study with no RLD for indian regulatory submission (CDSCO). The particular test product is PPI drug Delayed release capsule 40 mg with dual delayed release technology (DDR) formulation and it provides two distinct drug release periods in the GI tract.

Test product (capsules) contain a mixture of pellets 20 mg (releases MT 70% in 45 min at pH 8.0 when it reaches proximal duodenum) &  EC DR tablets 20 mg (release MT 70% in 210 min at pH 7.4 distal portion of small intestine), each providing a different pH-dependent dissolution profile.

The RLD product is available for 20 mg strength with delayed release but it is not DDR in the US market. 

Please let me know your thoughts on this.

Thanks in advance.

Regards,
Sriram