Mauricio Sampaio ★ Brazil, 2015-03-31 20:59 (3474 d 13:25 ago) Posting: # 14642 Views: 15,365 |
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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? Edit: Category changed. [Helmut] |
mittyri ★★ Russia, 2015-04-01 10:01 (3474 d 00:23 ago) @ Mauricio Sampaio Posting: # 14646 Views: 13,452 |
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Dear Mauricio, I've found just this one (patients with asthma, active metabolite CIC was determined) — Kind regards, Mittyri |
Mauricio Sampaio ★ Brazil, 2015-04-02 09:11 (3473 d 01:13 ago) @ mittyri Posting: # 14655 Views: 13,145 |
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Dear Mittyri, thank you so much! However, you sent me information about Ciclesonide instead of Cloperastine. Best Regards |
mittyri ★★ Russia, 2015-04-02 15:17 (3472 d 19:07 ago) @ Mauricio Sampaio Posting: # 14656 Views: 13,143 |
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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 ) — Kind regards, Mittyri |
Helmut ★★★ Vienna, Austria, 2015-04-02 16:05 (3472 d 18:19 ago) @ mittyri Posting: # 14657 Views: 13,773 |
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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 ) 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).— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Mauricio Sampaio ★ Brazil, 2015-07-13 08:13 (3371 d 02:10 ago) @ mittyri Posting: # 15071 Views: 11,643 |
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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! |
Mahesh M ★ India, 2018-07-13 14:09 (2274 d 20:15 ago) @ Mauricio Sampaio Posting: # 19044 Views: 7,228 |
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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 |