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项与 氨氯地平/氯沙坦钾/瑞舒伐他汀钙 相关的临床试验A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia
This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia.
During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.
As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.
An Open-label, Randomised, Single Dose, Three-way Crossover, Parallel Groups Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 to Respective Reference Dosages in Healthy Adult Male and Female Subjects Under Fasting Conditions
This is a three-period, three sequence, reference replicated, cross-over study to determine the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine and losartan tablets co-administered in two groups enrolling 102 healthy adult male and female subjects under fasting conditions.
A description of each treatment is provided below:
A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x 5 mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x 100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The treatments will be administered in accordance with the randomisation schedule as.
Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C All subjects will attend a screening visit within 28 days of their first dosing period (Day 1). The baseline assessments will be conducted the day before the first dosing.
In each treatment period, subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours post-dose.
The three treatment periods will be separated by a washout period of 10-17 days. Upon completion of the last dosing period, or early withdrawal, subjects will return to the clinical unit within 14-21 days for a follow up visit.
100 项与 氨氯地平/氯沙坦钾/瑞舒伐他汀钙 相关的临床结果
100 项与 氨氯地平/氯沙坦钾/瑞舒伐他汀钙 相关的转化医学
100 项与 氨氯地平/氯沙坦钾/瑞舒伐他汀钙 相关的专利(医药)
100 项与 氨氯地平/氯沙坦钾/瑞舒伐他汀钙 相关的药物交易