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

Official title

An Open-Label, Randomized, Single Dose Study, to Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets Manufactured by Sichuan Credit Pharmaceutical Co., Ltd, China In Healthy Participants Under Fasting Conditions.

Overview

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

Detailed description

This is An Open-Label, Randomized, Single Dose Study, to assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Participants under Fasting Conditions. A total number of 32 normal healthy adult human subjects will be included in the study. Vitamin C (Ascorbic acid), Vitamin B2 (Riboflavin) and Astragaloside IV in plasma samples will be assayed using a validated method LC-MS/MS analytical method.

Interventions

• Dietary supplement Vitamin C, Vitamin B2, Astragalus Root dry extract etc
  This study to assess the pharmacokinetic profile of single ascending dose

Primary outcome measures

• 1. Pharmacokinetic analysis [Time frame: 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.]

Eligibility criteria

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.
• 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

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.
• 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.
• Habituated to drinking tea or coffee (more than 5 cups/day) or inability to abstain during sample collection.
• Habituated to tobacco/tobacco containing products or inability to abstain during entire course of the study.
• A positive result for hepatitis B \& C, HIV antibody and syphilis (VDRL) tests.
• Use of any recreational drugs or history of drug addiction or testing positive for urine drugs of abuse prior to check-In.
• History of difficulty with donating blood.
• Donation of blood/ Plasma (1 unit: 350 mL / 450 mL) within 90 days prior to sample collection.
• The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the sample collection.
• Study participants having any deformity that will affect venous access for Cannulation.
• Study participants having any history of surgery in the previous six months.
• Difficulty in swallowing investigational medicine products.
• Known or suspected increased susceptibility to infection.
• Presence of any flu symptoms.
• Presence of any clinically significant abnormal values during screening.
• Recent history of dehydration from diarrhoea, vomiting or any other reason within period of 07 days prior to study Check-In.
• Use of any prescribed or OTC medicinal products including vitamins, herbal supplements and minerals during the within two weeks prior to investigational products administration in period I.
• Female participants who have used implanted or injected hormonal contraceptives within 14 days before dosing.
• Female participants are currently breast-feeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Basic science

Study locations

India · 1 center

• Clinispec Research Pvt Ltd — Hyderabad

Identifiers

NCT: NCT07664657 · CSR-061-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗