[Translation] A randomized, open-label, single-dose, two-period, self-crossover bioequivalence study of perindopril indapamide tablets in healthy subjects under fasting and fed conditions

主要研究目的：以国药集团工业有限公司研制的培哚普利吲达帕胺片（规格：培哚普利叔丁胺盐4 mg，吲达帕胺1.25 mg）为受试制剂，按生物等效性研究的有关规定，与施维雅（天津）制药有限公司生产的培哚普利吲达帕胺片（参比制剂，商品名：百普乐®，规格：培哚普利叔丁胺盐4 mg，吲达帕胺1.25 mg）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：观察培哚普利吲达帕胺片受试制剂和参比制剂（规格：培哚普利叔丁胺盐4 mg，吲达帕胺1.25 mg）在健康受试者中的安全性。

[Translation]

Main research purpose: Using the perindopril indapamide tablets (specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) developed by Sinopharm Group Industrial Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the relative bioavailability in healthy humans was compared with the perindopril indapamide tablets (reference preparation, trade name: Bipro®, specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) produced by Servier (Tianjin) Pharmaceutical Co., Ltd., to investigate the human bioequivalence of the two preparations. Secondary research purpose: Observe the safety of the test preparation and reference preparation of perindopril indapamide tablets (specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) in healthy subjects.

Start Date04 Aug 2023

Sponsor / Collaborator

China National Pharmaceutical Industry Corp. Ltd.

NCT05683301

/ CompletedPhase 4IIT

Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

Hypertension is a leading cause of morbidity and mortality globally. Although multiple drugs are frequently used to treat it, in the South Asian context, evidence is lacking on best drug combinations. This trial aims to compare efficacy of three single-pill combinations of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure among 1968 individuals with hypertension. The trial is a single-blind randomized controlled trial spread across 37 hospitals in India.
Single Pill combinations (SPCs): 1) Amlodipine + Perindopril, 2) Perindopril + Indapamide, 3) Amlodipine + Indapamide

Start Date30 Aug 2022

Sponsor / Collaborator

Centre for Chronic Disease Control

[+2]

CTR20220865

/ CompletedNot Applicable

培哚普利吲达帕胺片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）、口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial), oral, two-formulation, two-sequence, two-period, crossover human bioequivalence study of perindopril indapamide tablets in healthy Chinese subjects

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂培哚普利吲达帕胺片（规格：4mg/1.25mg；生产企业：天津力生制药股份有限公司）和参比制剂培哚普利吲达帕胺片（商品名：百普乐；规格：4mg/1.25mg；持证商：施维雅（天津）制药有限公司，生产企业：施维雅（天津）制药有限公司）后的药代动力学特征，进行药代动力学关键参数的比较，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂培哚普利吲达帕胺片和参比制剂培哚普利吲达帕胺片（百普乐）在中国健康受试者的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation Perindopril Indapamide Tablets (Specifications: 4mg/1.25mg; Manufacturer: Tianjin Lisheng Pharmaceutical Co., Ltd.) and the reference preparation Perindopril Indapamide Tablets (Trade name: Biprole; Specifications: 4mg/1.25mg; Licensee: Servier (Tianjin) Pharmaceutical Co., Ltd., Manufacturer: Servier (Tianjin) Pharmaceutical Co., Ltd.) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, to compare the key pharmacokinetic parameters, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation Perindopril Indapamide Tablets and the reference preparation Perindopril Indapamide Tablets (Biprole) in Chinese healthy subjects.

Start Date18 May 2022

Sponsor / Collaborator

Tianjin Lisheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Perindopril/Indapamide

100 Translational Medicine associated with Perindopril/Indapamide

100 Patents (Medical) associated with Perindopril/Indapamide

199

Literatures (Medical) associated with Perindopril/Indapamide

01 Feb 2025·Diabetes Care

Intensive Glucose Lowering and Its Effects on Vascular Events and Death According to Age at Diagnosis and Duration of Diabetes: The ADVANCE Trial

Article

Author: Zoungas, Sophia ; Mancia, Giuseppe ; Hamet, Pavel ; Poulter, Neil ; Marre, Michel ; Harrap, Stephen ; Ohkuma, Toshiaki ; Chalmers, John ; Woodward, Mark ; Harris, Katie

OBJECTIVETo compare the vascular effects of pursuing more versus less glucose lowering in patients with younger or older age at diabetes diagnosis, and with shorter or longer diabetes duration.RESEARCH DESIGN AND METHODSWe studied 11,138 participants from the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial, classified into subgroups defined by age at diabetes diagnosis (≤50, >50–60, and >60 years) and diabetes duration (≤5, >5–10, and >10 years).RESULTSIntensive glucose lowering significantly lowered the risk of the primary composite outcome of major macrovascular and microvascular events (hazard ratio 0.90, 95% CI 0.82–0.98) with no evidence of heterogeneity in the proportional effects across subgroups defined by age at diagnosis or diabetes duration (P for heterogeneity = 0.86 and 0.47, respectively). Similar consistent treatment effects were also observed for all-cause death, cardiovascular death, and the components of major vascular events.CONCLUSIONSIntensive glucose lowering may be recommended irrespective of age at diagnosis or diabetes duration.

01 Jan 2025·Cerebral Circulation - Cognition and Behavior

Effect of randomised blood pressure lowering treatment and intensive glucose control on dementia and cognitive decline according to baseline cognitive function and other subpopulations of individuals with type 2 diabetes: Results from the ADVANCE trial

Article

Author: MacMahon, Stephen ; Hamet, Pavel ; Poulter, Neil ; Woodward, Mark ; Chalmers, John ; Shajahan, Sultana ; Xu, Ying ; Mancia, Giuseppe ; Gong, Jessica ; Harrap, Stephen ; Harris, Katie ; Marre, Michel ; Anderson, Craig

Background and aimsAccumulating evidence indicates that reducing high blood pressure (BP) prevents dementia and mild cognitive impairment (MCI). Furthermore, although diabetes is a risk factor for dementia and MCI, there is uncertainty of the effect of intensive glucose control on these endpoints. This study aimed to determine the effects of BP-lowering (vs placebo) and intensive glucose-lowering (vs standard control) treatments according to baseline cognition and other characteristics on dementia and cognitive decline (CD) in people with type 2 diabetes mellitus (T2DM).MethodsThe Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial involved 11,140 individuals with T2DM. The effects of BP-lowering and intensive glucose-lowering treatments were explored in subgroups of baseline Mini-Mental State Examination (MMSE), categorised as cognitively normal (scores ≥28) and cognitive impairment (scores <28). The primary outcome was a composite of dementia/CD that accounted for the competing risk of death. Multinomial regression models, adjusted for common cardiovascular risk factors, were used to estimate odds ratios (OR) with 95 % confidence intervals (CI) of the effects of the treatments on dementia/CD. Homogeneity of effects by subgroups were evaluated using interaction terms in the models. A two-sided p value <0.05 was regarded as statistically significant.ResultsBP-lowering treatment (vs. placebo) was associated with a lower odds of dementia/CD in participants with cognitive impairment (OR 0.76, 95 % CI (0.59-0.99)) but not in those cognitively normal (OR 1.05, 95 % CI (0.92-1.21); p for interaction 0.03). Those with a history of cardio-renal-metabolic syndrome did not experience a benefit of active BP lowering treatment compared with placebo on dementia/CD. There were no further subgroup effects of BP-lowering treatment. The effect of intensive glucose lowering (vs standard control) on the odds of dementia/CD did not vary by baseline cognition subgroup. However, it did vary by level of blood glucose at baseline (<7.9 mmol/L OR 1.12, 95 % CI (0.96-1.30) vs ≥ 7.9 mmol/L 0.87 (0.75-1.00); p for interaction 0.02) and duration of T2DM (<10 years OR 0.92 (0.81-1.05) vs ≥10 years 1.16 (0.97-1.38); p for interaction 0.04).ConclusionsThis study suggests greater effects of BP-lowering treatment in those with early loss of cognitive function than in those cognitively normal. There were also differential effects of intensive glucose-lowering on dementia and CD according to levels of blood glucose and duration of diabetes in people with T2DM.Clinical trial registrationADVANCE is registered with ClinicalTrials.gov: number NCT00145925.

01 Jan 2025·British Journal of Clinical Pharmacology

Frailty in clinical drug trials: Frailty assessments, subgroup analyses and outcomes

Review

Author: Nguyen, Tu N. ; Lindley, Richard I. ; Ahmad, Fahed

AbstractWith population ageing, drug trials are increasingly turning their attention to including older, frailer people. This review aimed to provide an overview of how frailty was assessed in published studies related to clinical pharmacological trials, and on the interaction of frailty on the efficacy of the treatments. We searched MEDLINE, EMBASE and Cochrane for clinical drug trials in older people. A total of 4031 abstracts were screened and 17 relevant studies were included in this review. We summarized the findings of these 17 trials into five main clinical areas: cardiovascular (eight studies), cognition (one study), vaccination (two studies), cancer (four studies) and other (two studies). Frailty was assessed retrospectively in most of the studies. Frailty was treated as an ordinal variable (with different levels of frailty) or binary variable (frail/non‐frail) using cut‐offs in some studies, and as a continuous in some other studies. The effect of frailty on the treatment efficacy was not consistent among the studies. While several trials, such as the Action in Diabetes and Vascular Disease—Preterax and Diamicron Modified Release Controlled Evaluation trials, the Systolic Blood Pressure Intervention Trial and the Aspirin in Reducing Events in the Elderly trial, showed some reduced effects of the treatment in frail patients, most of the trials showed that the benefits of the treatment are not affected by frailty. Some trials even showed that the benefits of the treatment were more significant in frailer patients (the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure and the Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure trials). The results of this review suggest that routine measurement of frailty in participants in clinical drug trials would improve our knowledge of the effect of treatment in the frail and identify those who have more or least to gain from treatment.

100 Deals associated with Perindopril/Indapamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09BA04	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	China	Servier Tianjin Pharmaceutical Co. Ltd.	07 Sep 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FIXE (ESH2019)	Not Applicable	Diabetes Mellitus \| Hypertension	28	Perindopril/Indapamide/Amlodipine 10/2.5/10 mg	(cnqgxuxjxb) = gdjsrcyksk ewekqgrfsg (vhshivpnrk ) View more	Positive	01 Jul 2019
ESH2018	Not Applicable	Hypertension	46	Perindopril/Indapamide/Amlodipine 5/1.25/5 mg	(iqxavaxyvu) = jcrzcfdwrt pditvyjuks (uqkyeaizyq ) View more	Positive	01 Jun 2018
NCT00145925 (ADVANCE, ASN2015)	Phase 3	Diabetes Mellitus \| Vascular Diseases UACR	9,195	PreterAx (³30% decrease in UACR)	(efttruekiv): HR = 0.1 (95% CI, 0.01 - 0.79)	Positive	03 Nov 2015
NCT00145925 (ADVANCE, ASN2015)	Phase 3	Diabetes Mellitus \| Vascular Diseases UACR	9,195	PreterAx (<30% decrease to <30% increase in UACR)	(efttruekiv): HR = 0.1 (95% CI, 0.01 - 0.79)	Positive	03 Nov 2015
PP.21.01 (ESH2015)	Not Applicable	Diabetes Mellitus \| Hypertension	34	Perindopril/Indapamide 10/2.5 mg	(omlhktxlpr) = azrhkqrrvg nwsdxmzily (zeutnzvgzz, 18.9) View more	Positive	01 Jun 2015
START STUDY (ESH2010)	Not Applicable	Essential Hypertension	714	Perindopril 2 mg / Indapamide 0.625 mg	mwlyuvbjsi(hngahmblbn) = urneppxusx hsdjdzzsny (imiklfjsku )	Positive	01 Jun 2010
NCT00145925 (ADVANCE, Pubmed \| Diabetologia)	Phase 3	Diabetes Mellitus, Type 2	11,140	Preterax (Normal cognitive function)	lgxuakeplv(tryjangyci): HR = 1.33 (95% CI, 1.16 - 1.54), P-Value = < 0.03 View more	-	01 Nov 2009
NCT00145925 (ADVANCE, Pubmed \| Diabetologia)	Phase 3	Diabetes Mellitus, Type 2	11,140	Preterax (Mild cognitive dysfunction)		-	01 Nov 2009

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