Bioavailability and PharmacokineticsSaninovaNCT07664657
To Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Participants Under Fasting Conditions
A study testing Vitamin C, Vitamin B2, Astragalus Root dry extract etc in people with Bioavailability and Pharmacokinetics, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.
Trial summary
An open-label, randomized, single dose study to assess dose proportionality and pharmacokinetic linearity in healthy participants under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability and Pharmacokinetics
- What is being tested?
- Vitamin C, Vitamin B2, Astragalus Root dry extract etc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
An open-label, randomized, single dose study to assess dose proportionality and pharmacokinetic linearity in healthy participants under fasting condition.
Read the 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.
- Conditions
- Bioavailability and Pharmacokinetics
- Being tested
- Vitamin C, Vitamin B2, Astragalus Root dry extract etc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C, Vitamin B2, Astragalus Root dry extract etcDietary supplement
This study to assess the pharmacokinetic profile of single ascending dose
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Saninova Tablets (vitamin C, vitamin B2, Astragalus Root dry extract etc.) Receives: Dietary Supplement: Vitamin C, Vitamin B2, Astragalus Root dry extract etc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability and PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single ascending dose study
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Credit Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664657
- Sponsor's protocol ID
- CSR-061-26
- Acronym
- Saninova
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07664657
- Acronym / sponsor ID
- Saninova / CSR-061-26
- Conditions
- Bioavailability and Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sichuan Credit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single ascending dose study
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Dietary Supplement: Vitamin C, Vitamin B2, Astragalus Root dry extract etcSaninova Tablets (vitamin C, vitamin B2, Astragalus Root dry extract etc.) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C, Vitamin B2, Astragalus Root dry extract etcThis study to assess the pharmacokinetic profile of single ascending dose | Dietary supplement | Test Arm |
Primary outcome
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.
Vitamin C (Ascorbic acid), Vitamin B2 (Riboflavin), Astragaloside IV in plasma samples will be assayed using a validated method LC-MS/MS analytical method
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C, Vitamin B2, Astragalus Root dry extract etc in people with Bioavailability and Pharmacokinetics, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hitesh Shah (+919821218347, hitesh@creditpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.