Bioequivalence and Bioavailability Forum

Dear Madam/Sir,

1. Quetiapine 200 mg XL multiple dose study is not advised in healthy subjects due to safety reasons.
   
2. What are the alternate approaches to conduct the study ?
   
3. Anyhow if anybody wants to go ahead with healthy subjects, can the following approach is acceptable provided the subject will be withdrawn in case of any safety issue during dose titration.

Days Dose
0 (Enrollment) Nil
1 50 mg XR (Innovator)
2 100 mg XR (Innovator)
3 200 mg XR (T or R )
4 200 mg XR (T or R )
5 200 mg XR (T or R )
6 200 mg XR (T or R ), profiling
7 Discharge
Washout 7 days (Dosing to dosing)
12 Enrollment 2
13 50 mg XR (Innovator)
14 100 mg XR (Innovator)
15 200 mg XR (R or T)
16 200 mg XR (R or T)
17 200 mg XR (R or T)
18 200 mg XR (R or T) profiling
19 Discharge

Thanks in advance.

Kind regards,