[Translation] A single-center, randomized, open-label, single-dose, fasting/fed, two-formulation, two-period, double-crossover bioequivalence study of famotidine calcium magnesium chewable tablets in Chinese healthy subjects

主要研究目的：福建省闽东力捷迅药业股份有限公司生产的法莫替丁钙镁咀嚼片（法莫替丁10 mg，碳酸钙800 mg，氢氧化镁165 mg）与Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Division持证的法莫替丁钙镁咀嚼片（商品名：Pepcid Complete，法莫替丁10 mg，碳酸钙800 mg，氢氧化镁165 mg）在健康受试者中的空腹/餐后单次给药、随机、开放、两周期、双交叉的生物等效性研究。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary study objective: A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of famotidine calcium magnesium chewable tablets (famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. and famotidine calcium magnesium chewable tablets (trade name: Pepcid Complete, famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) certified by Johnson and Johnson Consumer Inc Mcneil Consumer Healthcare Division in healthy subjects. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date-

Sponsor / Collaborator

Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

CTR20240252 / CompletedNot Applicable

法莫替丁钙镁咀嚼片在中国健康受试者中的单中心、随机、开放、空腹/餐后单次给药、两制剂、两周期、双交叉的生物等效性试验研究

主要研究目的：烟台荣昌制药股份有限公司生产的法莫替丁钙镁咀嚼片（法莫替丁10 mg，碳酸钙800 mg，氢氧化镁165 mg）与Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Division持证的法莫替丁钙镁咀嚼片（商品名：Pepcid Complete，法莫替丁10 mg，碳酸钙800 mg，氢氧化镁165 mg）在健康受试者中的空腹/餐后单次给药、随机、开放、两周期、双交叉的生物等效性研究。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary study objective: A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of famotidine calcium magnesium chewable tablets (famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) produced by Yantai Rongchang Pharmaceutical Co., Ltd. and famotidine calcium magnesium chewable tablets (trade name: Pepcid Complete, famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) certified by Johnson and Johnson Consumer Inc Mcneil Consumer Healthcare Division in healthy subjects. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date25 Feb 2024

Sponsor / Collaborator

Yantai Rongchang Pharmaceutical Co. Ltd.

NCT00944671 / CompletedPhase 1

A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water

A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.

Start Date01 Feb 2008

Sponsor / Collaborator

Johnson & Johnson Consumer and Personal Products Worldwide

100 Clinical Results associated with Famotidine/magnesium dihydroxide/Calcium carbonate

100 Translational Medicine associated with Famotidine/magnesium dihydroxide/Calcium carbonate

100 Patents (Medical) associated with Famotidine/magnesium dihydroxide/Calcium carbonate

100 Deals associated with Famotidine/magnesium dihydroxide/Calcium carbonate

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Heartburn	US	Johnson & Johnson Holdco (NA), Inc.	16 Oct 2000

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