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Originator Org.- |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.South Korea |
First Approval Date08 Aug 2025 |
/ CompletedNot Applicable 中国健康绝经后女性受试者空腹状态下口服雌二醇地屈孕酮片(0.5mg/2.5mg)的随机、开放、两序列、四周期、完全重复交叉设计生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period, fully replicated crossover bioequivalence trial of oral estradiol dydrogesterone tablets (0.5 mg/2.5 mg) in healthy postmenopausal women in China under fasting conditions.
主要研究目的
研究空腹状态下分别单次口服受试制剂雌二醇地屈孕酮片(规格:雌二醇0.5mg/地屈孕酮2.5mg;生产厂家:北京金城泰尔制药有限公司)与参比制剂雌二醇地屈孕酮片(商品名:Femoston-conti;规格:雌二醇0.5mg/地屈孕酮2.5mg;持证商:Mylan Products Ltd.,生产厂家:Abbott Biologicals B.V.)在中国健康绝经后女性受试者体内的药代动力学行为,评价空腹状态口服雌二醇地屈孕酮片两种制剂的生物等效性。
次要研究目的
评价中国健康绝经后女性受试者空腹状态下分别单次口服雌二醇地屈孕酮片的两种制剂后的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetic behavior of the test formulation, estradiol-dydrogesterone tablets (strength: estradiol 0.5 mg/dydrogesterone 2.5 mg; manufacturer: Beijing Jincheng Tai'er Pharmaceutical Co., Ltd.), and the reference formulation, estradiol-dydrogesterone tablets (trade name: Femoston-conti; strength: estradiol 0.5 mg/dydrogesterone 2.5 mg; licensee: Mylan Products Ltd., manufacturer: Abbott Biologicals B.V.), in healthy postmenopausal women in China under fasting conditions, and to evaluate the bioequivalence of the two formulations.
Secondary Objective: To evaluate the safety of the two formulations of estradiol-dydrogesterone tablets after single oral administration under fasting conditions in healthy postmenopausal women in China.
评价硝呋太尔制霉菌素阴道软胶囊制剂对照麦咪康帕®治疗阴道炎的临床有效性和安全性的验证性临床研究
[Translation] A confirmatory clinical study evaluating the clinical efficacy and safety of nifuratel-nystatin vaginal soft capsules as a control for micamicin® in the treatment of vaginitis.
主要目的:评价硝呋太尔制霉菌素阴道软胶囊与原研对照药品(商品名:麦咪康帕® )治疗阴道炎的临床有效性。
次要目的:评价硝呋太尔制霉菌素阴道软胶囊制剂治疗阴道炎的安全性。
[Translation] Primary objective: To evaluate the clinical efficacy of nifuratel-nystatin vaginal soft capsules compared to the original control drug (trade name: Maimicom®) in the treatment of vaginitis.
Secondary objective: To evaluate the safety of nifuratel-nystatin vaginal soft capsules in the treatment of vaginitis.
/ CompletedNot Applicable 中国健康绝经后女性受试者空腹和餐后状态下口服雌二醇地屈孕酮片(0.5mg/2.5mg)的随机、开放、两序列、四周期、完全重复交叉设计生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period, fully repeated crossover bioequivalence study of oral estradiol dydrogesterone tablets (0.5 mg/2.5 mg) in healthy Chinese postmenopausal women in the fasting and fed states
主要研究目的
研究空腹、餐后状态下分别单次口服受试制剂雌二醇地屈孕酮片(规格:雌二醇0.5mg/地屈孕酮2.5mg;生产厂家:北京金城泰尔制药有限公司)与参比制剂雌二醇地屈孕酮片(商品名:Femoston-conti规格:雌二醇0.5mg/地屈孕酮2.5mg;持证商:Mylan Products Ltd,生产厂家:Abbott Biologicals B.V.)在中国健康绝经后女性受试者体内的药代动力学行为,评价空腹、餐后状态口服雌二醇地屈孕酮片两种制剂的生物等效性。
次要研究目的
评价中国健康绝经后女性受试者空腹和餐后状态下分别单次口服雌二醇地屈孕酮片的两种制剂后的安全性。
[Translation] Primary Study Objectives
To investigate the pharmacokinetic behavior of the test formulation, estradiol dydrogesterone tablets (strength: estradiol 0.5 mg/dydrogesterone 2.5 mg; manufacturer: Beijing Jincheng Taier Pharmaceutical Co., Ltd.), and the reference formulation, estradiol dydrogesterone tablets (trade name: Femoston-conti, strength: estradiol 0.5 mg/dydrogesterone 2.5 mg; licensee: Mylan Products Ltd, manufacturer: Abbott Biologicals B.V.), in healthy Chinese postmenopausal women following single oral administration in the fasting and fed states. The aim was to evaluate the bioequivalence of the two formulations of estradiol dydrogesterone tablets in healthy Chinese postmenopausal women following single oral administration in the fasting and fed states.
Secondary Study Objectives
To evaluate the safety of the two formulations of estradiol dydrogesterone tablets in healthy Chinese postmenopausal women following single oral administration in the fasting and fed states.
100 Clinical Results associated with Beijing Jinchengtaier Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Beijing Jinchengtaier Pharmaceutical Co., Ltd.