The goal of this clinical study is to assess the relative bioavailability of Amlodipine for Oral Solution 5 mg of Brillian Pharma Inc. under fasting and fed conditions versus reference product Norvasc 5 mg tablets of Pfizer Labs under fasting in normal, healthy, adult, male,
Primary Objective:
To compare the relative bioavailability.
To assess the food effect in Test product (T1) (Fast) vs Test product (T2) (Fed) Amlodipine Oral Solution 5 mg of Brillian Pharma Inc.
Secondary Objective:
To monitor the safety and tolerability of a single oral dose of investigational medicinal products (IMPs).

开始日期2022-12-29

申办/合作机构

Accutest Research Laboratories India Pvt Ltd.

NCT05129137

/ Completed临床1期

Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) and Individual Nefopam Hydrochloride and Paracetamol Taken Alone or Concomitantly After Oral Single Dose

This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.

开始日期2021-11-29

申办/合作机构

Unither Pharmaceuticals SASU

[+1]

CTRI/2017/10/009982

/ Not yet recruitingN/A

A Multicenter, Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single-Dose, Two-way, Crossover, Bioequivalence, Pilot Study to Evaluate the Bioequivalence of Azathioprine Tablets USP 50mg of RPG Life Sciences Compared to ImuranÂ® 50 mg Tablets of Prometheus Laboratories Inc., USA in Adult Rheumatoid Arthritis Patients Under Fasting Condition

开始日期2017-10-16

申办/合作机构

RPG Life Sciences Ltd.

[+1]

100 项与 Accutest Research Laboratories India Pvt Ltd. 相关的临床结果

登录后查看更多信息

0 项与 Accutest Research Laboratories India Pvt Ltd. 相关的专利（医药）

登录后查看更多信息

项与 Accutest Research Laboratories India Pvt Ltd. 相关的文献（医药）

2018-03-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

Novel bio analytical method development, validation and application for simultaneous determination of nebivolol and S-amlodipine in human plasma using ultra performance liquid chromatography-tandem mass spectrometry

3区 · 医学

Article

作者: Jangid, Arvind G ; Suhagia, B N ; Desai, Nirmal ; Patel, Bhargav M

A sensitive and specific ultra-performance liquid chromatography tandem mass spectrometric (UPLC-MS/MS) method has been developed, validated and applied for the assay of Nebivolol and S-amlodipine in human plasma. Sample extraction was carried out through hybrid extraction method from 250 μL of human plasma sample. Linearity of the method was (r ≥ 0.9996) was found to be dynamic for both the analytes over concentration range of 25.0-4000 pg/mL. Chromatographic separation was achieved on UPLC column {Waters Acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 micrometer)} with the mobile phase composition of 0.1% (v/v) formic acid in 5 mM Ammonium formate in water-acetonitrile (20:80, %v/v). Analytes Stability was assured under different requisite conditions in human plasma, reconstitution solution and diluents. Inter and intra-day assay precision and relative error (accuracy) were within ±5% for both analytes. The method was applied and reproduced to support a pharmacokinetic study of 5 mg Nebivolol (NEB) and 2.5 mg S-amlodipine (LAM) tablet on 9 healthy subjects.

2013-08-01·Journal of Pharmaceutical Analysis2区 · 医学

Application of UPLC–MS/MS for separation and quantification of 3α-Hydroxy Tibolone and comparative bioavailability of two Tibolone formulations in healthy volunteers

2区 · 医学

ArticleOA

作者: Mistri, Hiren ; Shinde, Vijay P ; Patel, P K ; Pudage, Ashutosh ; Jangid, Arvind

A novel, fast, sensitive and robust method based on ultra-performance liquid chromatography coupled to atmospheric pressure electrospray ionization tandem mass spectrometry (UPLC-ESI-MS/MS) has been developed to separate two Tibolone stereoisomers i.e., 3α-Hydroxy Tibolone and 3β-Hydroxy Tibolone and to quantify 3α-Hydroxy Tibolone using p-toulenesulfonyl isocyanate (PTSI) as a derivatizing reagent in human plasma. 3α-Hydroxy Tibolone-¹³CD₃ was used as an internal standard (IS). The analyte and IS were extracted from human plasma by liquid-liquid extraction using ethyl acetate. Extracted samples were analyzed by UPLC-ESI-MS/MS. Chromatography was performed using binary gradient on UPLC analytical column. A linear calibration curve over the range of 0.100-35.000 ng/mL was obtained and lower limit of quantification (LLOQ) was 0.100 ng/mL demonstrating acceptable accuracy and precision. This method was successfully applied to a pharmacokinetic study in order to compare a test Tibolone 2.5 mg formulation vs. a reference 2.5 mg Tibolone tablet formulation in 50 post-menopausal/surgical menopause female human volunteers under fasting conditions. It is concluded that test formulation of Tibolone is bioequivalent to reference formulation of Tibolone.

Asian Journal of Chemistry

Simultaneous determination of simvastatin, simvastatin acid, ramipril and ramiprilate in human plasma by liquid chromatography-tandem mass spectrometry

作者: Pudage, Ashutosh ; Joshi, Santosh S. ; Vaidya, Vikas V. ; Parekh, Sagar A.

A rapid and sensitive liquid chromatog.-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of simvastatin and its in vivo generated drug simvastatin acid along with ramipril and its active metabolite ramiprilate in human plasma.After solid phase extraction (SPE) the analytes and IS were chromatographed on a hypurity C18 (150 mm × 4.6 mm i.d, 5 μm particle size) column using 50 μL injection volume with a run time of 6 min.An isocratic mobile phase consisting of 4 mmol/L ammonium acetate (pH 3.00): acetonitrile (20:80, volume/volume) was used to sep. all these drugs.The precursor and product ions of these drugs were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring mode (MRM) with polarity switch.The proposed method was validated over the range of 0.25 ng/mL to 50 ng/mL for simvastatin and simvastatin acid, 0.25 ng/mL to 40 ng/mL for ramipril and 1.00 to 40 ng/mL for ramiprilate.Inter-batch and intra-batch precision (% CV) across 5 validation runs (LLOQ, LQC, MQC, HQC and ULOQ QC) was less than 14 for all the analytes.The accuracy determined for all the analytes at these levels was within ± 14 % in terms of relative error.

100 项与 Accutest Research Laboratories India Pvt Ltd. 相关的药物交易

登录后查看更多信息

100 项与 Accutest Research Laboratories India Pvt Ltd. 相关的转化医学

登录后查看更多信息