To Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Participants Under Fasting Conditions

NCT07664657 | Not Yet Recruiting

• 1 other identifier: CSR-061-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, randomized, single dose study to assess dose proportionality and pharmacokinetic linearity in healthy participants under fasting condition.

Conditions

Bioavailability and Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 1. Pharmacokinetic analysis

  Vitamin C (Ascorbic acid), Vitamin B2 (Riboflavin), Astragaloside IV in plasma samples will be assayed using a validated method LC-MS/MS analytical method

  Pharmacokinetic plasma samples collected over 72 hours for Vitamin C. Pharmacokinetic plasma samples collected over 12 hours for Vitamin B2. Pharmacokinetic plasma samples collected over 24 hours for Astragaloside IV.

Study Arms (1)

Test Arm

EXPERIMENTAL

Saninova Tablets (vitamin C, vitamin B2, Astragalus Root dry extract etc.)

Dietary Supplement: Vitamin C, Vitamin B2, Astragalus Root dry extract etc

Interventions

Vitamin C, Vitamin B2, Astragalus Root dry extract etc DIETARY_SUPPLEMENT

This study to assess the pharmacokinetic profile of single ascending dose

Test Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Male participants who are willing to maintain the abstain sexual contact by maintaining the birth control such as, a latex or synthetic condom, Vasectomy and tubal sterilization every time they have sexual intercourse with a female of reproductive potential during treatment and for one week after the final dose.
• For Female Participants
• Participant having negative β-hCG (serum pregnancy or urine pregnancy) test and Hormone assay (FSH).
• Child bearing potential willing to practice an acceptable method of birth control for the duration of the study and until three weeks after the last dose as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence from the date of screening until the completion of study and for one week after the final dose, or
• Post-menopausal for at least 1 year, or.
• Female participants should not be pregnant or lactating, and, should practice abstention or contraception during the study and for one week after the final dose of the study. Gynecological and breast examinations (for females) will be done before check in of each cohort only

You may not qualify if:

• 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.
• History or presence of certain laboratory tests eg: blood glucose and occult blood measurements, hemolysis, scurvy.
• History or presence of concomitant use of Warfarin, Aspirin, Deferoxamine, Estrogen-containing oral contraceptives, Paracetamol.
• History or presence of Hypersensitivity to riboflavin or any formulation component.
• History or presence of bright yellow discoloration of urine, certain diagnostic tests, Hypersensitivity reactions.
• History or presence of severe liver dysfunction, severe hepatic impairment, Chronic alcohol consumption.
• History or presence of concomitant use of Chlorpromazine, Imipramine, oral contraceptives, Methotrexate and Probenecid.
• History or presence of Hypersensitivity to Astragalus or related plant species.
• Participants having history of autoimmune diseases eg: Systemic Lupus Erythematosus, Rheumatoid Arthritis, or Multiple Sclerosis, immunosuppressive therapy e.g: Cyclosporine.
• Participants having history of bleeding disorders, anticoagulant therapy.
• History or presence of hypotension or hypoglycemia.
• History or presence of concomitant use of Cyclosporine, antihypertensive drugs e.g: Amlodipine, antidiabetic agents e.g: Metformin, anticoagulants or antiplatelet drugs e.g: Clopidogrel, diuretics.
• If any participants, blood pressure, vitals beyond the limits that participant will be excluded from the study.
• Female participants with positive β-hCG (serum pregnancy) at the time of screening and prior to check-In.

Sponsors & Collaborators

• Sichuan Credit Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Clinispec Research Pvt Ltd

Hyderabad, Telangana, 500043, India

Location

MeSH Terms

Interventions

Ascorbic Acid; Riboflavin

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Central Study Contacts

Hitesh Shah

CONTACT

+919821218347; hitesh@creditpharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose study

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

IN (1)