To Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Parti… (NCT07664657) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
To Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Participants Under Fasting Conditions
India32 participantsStarted 2026-06
Plain-language summary
An open-label, randomized, single dose study to assess dose proportionality and pharmacokinetic linearity in healthy participants under fasting condition.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participation is truly voluntarily.
. Healthy adult, human Participants between 18 to 45 years of age (both inclusive) and weighing at least 50 kgs.
. Having a Body Mass Index (BMI) between 18.50 and 30.00 Kg/m2 (both inclusive) calculated as weight in kg / height in m2.
. Have normal clinically findings as judged by investigators during screening within 28 days prior to administration of first dose of study drug, medical history and examination, laboratory evaluations, 12-lead ECG recordings, chest X-ray will be conducted.
. If any participants, blood pressure, vitals within the limits that participant will include into the study.
. Able to comply with the study procedures, in the opinion of the PI/CI.
. Non-smoker and non-alcoholic.
. Able to give written consent for participation in the study.
Exclusion criteria
. History or presence of Hypersensitivity to ascorbic acid or any component of the formulation.
. Participants having history of oxalate kidney stones, renal disorders, iron overload disorders eg: hemochromatosis, Glucose-6-Phosphate Dehydrogenase deficiency.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Pharmacokinetic analysis
Timeframe: Pharmacokinetic plasma samples collected over 72 hr for Vitamin C. Pharmacokinetic plasma samples collected over 12 hr for Vitamin B2. Pharmacokinetic plasma samples collected over 24 hr for Astragaloside IV.