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Accession number;05A0670255
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| Title;Bioequivalence study of novel injectable Famotidine solution E1170 and conventional freeze-dried injectable Famotidine agent |
| Author;
FURUIE HIDETOSHI
(Kyushurinshoyakurikurinikku)
KANDA MAYUKO
(Kyushurinshoyakurikurinikku)
IMAZUYA SATOKO
(Kyushurinshoyakurikurinikku)
MATSUGUMA KYOKO
(Kyushurinshoyakurikurinikku)
MURAKAMI MAKOTO
(Kyushurinshoyakurikurinikku)
IRIE SHIN
(Kyushurinshoyakurikurinikku)
ATSUTA YUTAKA
(Yamanouchi Pharmaceutical Co., Ltd., JPN)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.21;NO.7;PAGE.733-741(2005)
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| Figure&Table&Reference;FIG.2, TBL.4, REF.4 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objective: The primary objective was to evaluate the bioequivalence of novel injectable Famotidine solution E1170 and conventional freeze-dried injectable Famotidine agent. The secondary objective was to evaluate the safety of these agents. Design: Two way crossover open-label study. Method: E1170 and conventional freeze-dried injectable Famotidine were injected intramuscularly to 18 healthy Japanese male adults at the dose of 20 mg to study bioequivalence and safety of both dosage form. Results: 1) Bioequivalence: The 90 % confidence interval geometric mean ratio of Cmax and AUCt were 0.86-1.00 and 0.98-1.04. They implement the criteria of bioequivalence. Thus, novel injectable Famotidine solution E1170 and conventional freeze-dried injectable Famotidine agent were considered to be bioequivalent. 2) Safety: Seventeen out of 18 subjects felt more painful by E1170 injection than by conventional freeze-dried injectable Famotidine. One out of 18 felt almost equally painful by injection of both dosage form. No adverse events were observed. Conclusion: Novel injectable Famotidine solution E1170 and conventional freeze-dried injectable Famotidine agent were safe and considered to be bioequivalent (author abst.) |
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