This study's design as an open-label, single-period, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of seven Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.
Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.

Start Date17 Mar 2025

Sponsor / Collaborator

Amazentis SA

[+1]

NCT06362018

/ CompletedNot Applicable

A Comparative Pharmacokinetic Profiles of Five Urolithin A Formulations in Healthy Volunteers: A Randomized, Open-label, Single-dose, Parallel-arm Study

This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of five Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.
Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.

Start Date07 May 2024

Sponsor / Collaborator

Amazentis SA

[+1]

CTRI/2023/09/058165

/ Not yet recruitingNot Applicable

To study the safety and efficacy of Panchakarma Essential (Katibasti) in the management of lowerback pain. - Nil

Start Date02 Oct 2023

Sponsor / Collaborator

Mprex Healthcare Pvt Ltd.

100 Clinical Results associated with Mprex Healthcare Pvt Ltd.

0 Patents (Medical) associated with Mprex Healthcare Pvt Ltd.

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03 Apr 2025·Drug Metabolism and Personalized Therapy

An open-label, single dose, safety and pharmacokinetic study of Withania somnifera root extract in healthy volunteers

Article

Author: Kshirsagar, Ketan ; Mehta, Anirudh ; Sharma, Eshita ; Ganu, Gayatri ; Shah, Ashwin ; Mahale, Umakant ; Nair, Sujit

AbstractObjectivesWithania somnifera (WS), also known as Ashwagandha, is a health-beneficial Ayurvedic medicinal plant with great potential as an adaptogen with rejuvenating and anti-aging effects. However, studies investigating pharmacokinetics (PK), safety, and tolerability of WS on humans are limited. The present study evaluated PK, safety, and tolerability of WS root extract (2.5 % total withanolides) capsules upon oral administration of two capsules of 200 mg each (total 400 mg) in healthy male and female volunteers.MethodsAn open label, single dose, clinical design comprising healthy volunteers was employed. The study evaluated PK parameters of the four bioactive constituents viz. withanoside IV, withaferin A, 12-deoxy-withastramonolide, and withanolide A in WS root extract after analysis of plasma using a validated UHPLC-MS/MS method. Further, safety and tolerability assessment for vital signs, testing for organ function, urine examination, X-ray, ECG, as well as adverse events profile were also investigated.ResultsAfter oral administration of 2 WS capsules (200 mg each), the participants reported normal physical, hematological, and biochemical parameters with no abnormalities in safety metrics. For the four bioactives, the exposure parameters range between 0.472 and 4.468 ng/mL (Cmax), 1.000–1.416 h (Tmax), and 2.051–13.319 ng/mL*h (AUC 0-t). Further, t1/2 (1.696–4.377 h), lambda_z (0.141–0.282 L/h), Cl/F (0.065–0.954 mg/(ng/ml)/h), AUMC 0-inf_obs (21.720–80.485 ng/mL*hˆ2) and MRT 0-inf_obs (3.680–7.516 h) also differed for each bioactive.ConclusionsThe present study elucidated the PK of WS and showed that healthy male and female volunteers may safely consume WS capsules at a dose of 400 mg (2 capsules of 200 mg) without any harmful effects.

25 Feb 2025·Cureus

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of a Polyherbal Formulation in Men With Erectile Dysfunction

Article

Author: Dhavale, Shrikant G ; Kolhe, Sanman S ; Kuber, Vinod K ; Dev, Aditya ; Shintre, Somesh S ; Padmanabhan, Sriram ; Ganu, Gayatri P ; Kolsure, Pramod K ; Nagore, Dheeraj H

Introduction Erectile dysfunction (ED) is a prevalent condition impacting men worldwide, often causing significant reductions in quality of life, emotional well-being, and relationship satisfaction. ED currently affects approximately 100 million men worldwide, with its prevalence projected to rise to 320 million by 2025, particularly in developing nations. Notably, nearly half of all men aged 40 and above experience some degree of ED, underscoring its widespread impact on male health. Existing treatments, while available, frequently fall short in terms of efficacy and safety, underscoring the demand for innovative and safer therapeutic alternatives. Methods Eighty-five participants completed the study and were randomly assigned to receive either the test treatment (polyherbal formulation) or a placebo, utilizing a computer-generated randomization list. The study protocol included screening (up to 14 days prior), baseline assessment (Day 0), and follow-up visits at day 30, day 60, and day 90 (± 5 days), allowing for thorough monitoring of outcomes. Results The test group exhibited significantly greater improvements in erectile function (92.2% vs. 34.8%), along with enhancements in sexual desire, orgasmic function, intercourse satisfaction, and overall satisfaction compared to the placebo group. Quality of erection scores also showed marked improvement in the test group. Additionally, serum testosterone levels increased by 46.5% in the test group compared to a mere 3.3% in the placebo group. Adverse events were mild and occurred with similar frequency in both groups (9.3% vs. 9.5%). Overall, the test group demonstrated robust efficacy and a favorable safety profile, presenting a promising therapeutic option for the management of ED. Conclusion The in-vitro phosphodiesterase type 5 (PDE5) assay and clinical study demonstrate the effectiveness of test intervention in managing ED and improving sexual health, with a favorable safety profile. Its synergistic herbal ingredients enhance efficacy, making it a promising solution in the management of ED.

01 Feb 2025·Pharmaceutical Research

Efficacy and Safety of Boswellia serrata and Apium graveolens L. Extract Against Knee Osteoarthritis and Cartilage Degeneration: A Randomized, Double-blind, Multicenter, Placebo-Controlled Clinical Trial

Article

Author: Nagore, Dheeraj ; Ganu, Gayatri ; Patkar, Hrishikesh ; Godse, Chhaya ; Mehta, Anirudh ; Mehta, Dilip ; Nair, Sujit ; Dipankar, D G ; Agarwal, Ramshyam ; Vaidya, Narendra

AbstractBackgroundOsteoarthritis is the prevailing form of inflammatory condition in joints of adults and the aging population, leading to long-term disability and chronic pain. Current therapeutic options have variable therapeutic efficacy and/or several side effects.MethodsA randomized, placebo-controlled, double-blind clinical trial was conducted in 62 participants using a nutraceutical [standardized Boswellia serrata Roxb. gum resin (300 mg) and Apium graveolens L. seed extract (250 mg)], to determine its safety and efficacy for supporting cartilage health and reduction in knee osteoarthritis symptoms. All participants were assessed for physical function and pain with the help of WOMAC, VAS, Physicians' Global Assessment for the six-minute walk test/pain. Knee X-ray, KOOS questionnaire score, and FACIT-F score were assessed. Additionally, inflammatory, cartilage degeneration and regeneration biomarkers in serum and urine were evaluated at baseline and after 90 days of treatment.ResultsOral administration of the nutraceutical resulted in prolonged symptomatic relief with reduced pain, stiffness, and swelling. Inflammatory (serum IL-7, IL-1, IL-6, hs-CRP, TNF-α, ESR) and cartilage degeneration biomarkers (serum CTX-II, COMP, MMP-3 and urinary CTX-II) were decreased in the nutraceutical group compared to baseline and placebo. Furthermore, serum N-propeptide of collagen IIA (PIIANP) and procollagen-type-C propeptide (PIICP) levels were increased in the nutraceutical group, suggesting collagen synthesis contributing to cartilage regeneration. At given doses for 90 days, there were no adverse effects based on the clinical examination, biochemical, hematological, and ECG analysis.ConclusionsTaken together, the combination of Boswellia and celery could be a safe and promising herbal nutraceutical option for managing osteoarthritis and cartilage health effectively.

100 Deals associated with Mprex Healthcare Pvt Ltd.

100 Translational Medicine associated with Mprex Healthcare Pvt Ltd.

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