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Mauricio Sampaio
Regular

Brazil,
2015-03-31 16:59

Posting: # 14642
Views: 8,933
 

 Cloperastine ISCV [Design Issues]

Hi all members from BEBAC!
I am looking for data of ISCV from Ciclesonide to calculate a sample size in bioequivalence study.
Somebody help me? :confused:



Edit: Category changed. [Helmut]
mittyri
Senior

Russia,
2015-04-01 06:01

@ Mauricio Sampaio
Posting: # 14646
Views: 7,553
 

 Cloperastine ISCV

Dear Mauricio,

I've found just this one (patients with asthma, active metabolite CIC was determined)

Kind regards,
Mittyri
Mauricio Sampaio
Regular

Brazil,
2015-04-02 05:11

@ mittyri
Posting: # 14655
Views: 7,419
 

 Cloperastine ISCV

Dear Mittyri, thank you so much! However, you sent me information about Ciclesonide instead of Cloperastine.:-|

Best Regards
mittyri
Senior

Russia,
2015-04-02 11:17
(edited by mittyri on 2015-04-02 11:36)

@ Mauricio Sampaio
Posting: # 14656
Views: 7,396
 

 Cloperastine ISCV

Dear Mauricio,

May be I didn't catch something, but your question was about Ciclesonide...
BTW you're right, it isn't easy to find the data about Cloperastine ISCV.
I would suggest that it isn't high according to this article (there is a link to the internal data where bioequivalence was showed with 12 subjects only, although in the year 1992 :-D)

Kind regards,
Mittyri
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2015-04-02 12:05

@ mittyri
Posting: # 14657
Views: 7,565
 

 Manufacturer’s PK data (inves­tigator’s brochure)

Hi Mittyri & Mauricio,

» I would suggest that it isn't high according to this article (there is a link to the internal data where bioequivalence was showed with 12 subjects only, although in the year 1992 :-D)

I don’t think that this was a BE-study at all. Smells of PK-modeling:

The pharmacokinetics of levocloperastine and racemic DL-cloperastine were comparable in a single-dose, crossover study in 12 healthy volunteers (six males and six females). After administration of 10 ml of oral suspension containing levocloperastine fendizoate 70.8 mg (corresponding to 40 mg of the chlorhydrate salt and 36 mg of the active prin­ciple) or the same amount of racemic levocloperastine, peak plasma concentrations of 10 μg/L were reached 2 to 4 hours after administration, with a lag-time of approximately 45 minutes before detection of the drug in the bloodstream, suggesting a gradual and pro­tracted absorption from the intestine. A two-compartmental model with absorption phase, corresponding to a tri-exponential concentration-time profile, best describes the pharmacokinetics of levocloperastine. The half-lives of levocloperastine and DL-clo­per­astine were, respectively, 0.80 and 0.86 h (distribution half-life), 1.68 and 2.16 h (eli­mi­nation half-life), and 6.58 and 6.95 h (terminal elimination half-life).

Their terminology is odd. I would rather say: 0.80/0.86 h (absorption t½), 1.68/2.16 h (dis­tri­bution t½), and 6.58/6.95 h (elimination t½).

Cheers,
Helmut Schütz
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Mauricio Sampaio
Regular

Brazil,
2015-07-13 04:13

@ mittyri
Posting: # 15071
Views: 5,965
 

 Cloperastine ISCV

Dear Mittyri,

I made a mistake. The correct is cloperastine.
Sorry! Therefore, thank you for Ciclesonide information!
As soon as possible I will share information of bioequivalence study of cloperastine.

Regards!:-D
Mahesh M
Regular

India,
2018-07-13 10:09

@ Mauricio Sampaio
Posting: # 19044
Views: 1,541
 

 Cloperastine ISCV

Dear Mauricio Sampaio,


» As soon as possible I will share information of bioequivalence study of cloperastine.

Any references for Pharmacokinetics and ISCV for Cloperastine.

Regards
Mahesh
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