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Registermultiple dose study [Design Issues]
EMA Published PAR regarding Metformin prolonged release tablet
14 May 2016 | Yaltormin SR 500 mg, 750 mg and 1000 mg Prolonged Release Tablets (metformin hydrochloride) - PL 29831/0655-0657; UK/H/5957/001-3/DC (1640Kb)
As per this PAR Applicant performed 5 BE study
1) 1000 mg Fasting
2) 1000 mg fed
3) 1000 mg fasting multiple dose study
4) 750 mg
5) 500 mg fed
As per SPC “No accumulation is observed after repeated administration of up to 2000mg of metformin as prolonged release tablets then why applicant performed multiple dose study?
As per PIL “You should take Glucophage SR with or immediately after food.” But applicant performed multiple dose study under fasting condition not under fed condition?
Kindly share your thoughts on that?
Regards
M
Edit: PAR linked. [Helmut]
14 May 2016 | Yaltormin SR 500 mg, 750 mg and 1000 mg Prolonged Release Tablets (metformin hydrochloride) - PL 29831/0655-0657; UK/H/5957/001-3/DC (1640Kb)
As per this PAR Applicant performed 5 BE study
1) 1000 mg Fasting
2) 1000 mg fed
3) 1000 mg fasting multiple dose study
4) 750 mg
5) 500 mg fed
As per SPC “No accumulation is observed after repeated administration of up to 2000mg of metformin as prolonged release tablets then why applicant performed multiple dose study?
As per PIL “You should take Glucophage SR with or immediately after food.” But applicant performed multiple dose study under fasting condition not under fed condition?
Kindly share your thoughts on that?
Regards
M
Edit: PAR linked. [Helmut]
Complete thread:
- multiple dose studyMahesh M 2016-05-30 09:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 1999 Note for Guidance? Helmut 2016-05-30 13:37
- 1999 Note for Guidance? Mahesh M 2016-05-31 13:50
- Ask the applicant Helmut 2016-05-31 14:07
- Ask the applicant Mahesh M 2016-06-01 08:45
- Ask the applicant Helmut 2016-05-31 14:07
- 1999 Note for Guidance? Mahesh M 2016-05-31 13:50
- 1999 Note for Guidance? Helmut 2016-05-30 13:37
Ing. Helmut Schütz