A Pharmacokinetic Study of Single Oral Doses of Six Different Vitamin C Product Forms
- Conditions
- HealthyPharmacokinetic
- Registration Number
- NCT06471023
- Lead Sponsor
- DSM Nutritional Products, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - In good general health (i.e., no uncontrolled diseases or conditions) as deemed by<br> the investigator.<br><br> - Are able to swallow the study products, in whole.<br><br> - Have a body mass index (BMI) between 18.0 to 29.9 kg/m2 (inclusive).<br><br> - Must have suitable veins for repeated venipuncture.<br><br> - No nicotine and/or nicotine products, including smoking or vaping of any kind (e.g.,<br> cigarettes) for at least 3 months before screening.<br><br> - Have maintained consistent dietary habits (including supplement intake) and<br> lifestyle for the last 3 months before screening. Participants must be willing to<br> maintain these habits throughout the duration of the study, with the exception of<br> changes required by the vitamin C dietary restrictions.<br><br> - Willing to comply with the vitamin C dietary restrictions, 2 weeks prior to the<br> baseline and throughout the duration of the study until the last study visit.<br><br> - Agree to follow the restrictions on concomitant treatments as listed in the<br> protocol.<br><br> - Agree to follow the restrictions on lifestyle as listed in the protocol.<br><br> - Agree to use acceptable contraceptive methods as listed in the protocol.<br><br> - Willing and able to agree to the requirements of this study, willing to give<br> voluntary consent, able to understand and read the questionnaires, and carry out all<br> study-related procedures.<br><br> - Agrees not to donate blood until 3 months after study completion<br><br> - Must weigh = 58.9 kg (130 lbs) at screening<br><br>Exclusion Criteria:<br><br> - Individuals who are lactating, pregnant or planning to become pregnant during the<br> study.<br><br> - Have a known sensitivity, intolerability, or allergy to any of the study products or<br> their excipients.<br><br> - Have Type I diabetes, Type II diabetes, high blood pressure (=140 systolic or =90<br> diastolic mmHg), or thyroid disease.<br><br> - Have medical condition(s) known to interfere with absorption, distribution,<br> metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel,<br> acute or chronic pancreatitis, or pancreatic insufficiency).<br><br> - Have a history of heart disease, renal or hepatic impairment/disease, gout,<br> hemochromatosis, glucose-6-phosphate dehydrogenase deficiency, immune disorders<br> and/or immunocompromised (i.e., HIV/AIDS).<br><br> - Have a history of cancer (except localized skin cancer without metastases or in situ<br> cervical cancer), unless a minimum of 5 years before the screening visit have<br> elapsed since full recovery.<br><br> - Reports a clinically significant illness during the 28 days before the first dose of<br> study product, including acute inflammatory conditions or viral infections (e.g.,<br> cold, flu, COVID-19), or any other condition that, in the opinion of the<br> investigator, may be of a concern for the study.<br><br> - Participants must not exceed the ''high'' physical activity level as defined by the<br> International Physical Activity Questionnaire-- Short Form (IPAQ-SF) in the week<br> prior to baseline and agree to adhere to this requirement throughout the study<br> duration. A 'high' physical activity level is defend as having engaged in<br> vigorous-intensity physical activity on at least 3 days achieving a total of 1500 or<br> more Metabolic Equivalent of Task (MET)-minutes per week; or, having engaged in any<br> combination of walking, moderate-intensity, or vigorous-intensity physical<br> activities on 7 or more days achieving a total of 3000 or more MET-minutes per week.<br><br> - Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL<br> of blood within 30 days prior to the first PK visit or a blood donation of more than<br> 450 mL within 3 months prior to the first PK visit.<br><br> - Major surgery in 3 months before screening or planned major surgery during the<br> study.<br><br> - Are receiving treatments for or have been hospitalized in the last 12 months for<br> psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).<br><br> - Demonstrates a positive urine drug screen for compounds listed in the protocol, or<br> positive breath alcohol test at screening or baseline.<br><br> - Have a history of alcohol or substance abuse in the 12 months before screening<br> (including having been hospitalized for such in an in-patient or out-patient<br> intervention program).<br><br> - Currently consumes, on average, more than 2 standard alcoholic beverages a day or<br> has any habit of alcohol use that, to the opinion of the investigator, may be of a<br> concern for the study. A standard alcoholic beverage is defined as 12 ounces of<br> beer, 5 ounces of wine, or 1.5 ounces of liquor.<br><br> - Current enrolment or past participation in another study with any product(s) with at<br> least one active ingredient within 30 days before first dose of study product (or<br> screening) or longer, if the previous test product is deemed by the investigator to<br> have lasting effects that might influence the eligibility criteria or outcomes of<br> current study.<br><br> - Any other medical condition/situation or use of medications/supplements/therapies<br> that, in the opinion of the investigator, may adversely affect the participant's<br> ability to participate in the study or its measures or pose a significant risk to<br> the participant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioavailability of vitamin C compared between each of the liposomal formulations TP1 and TP2 to the traditional RP
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) of single doses of six vitamin C formulations;Pharmacokinetics (PK) of single doses of six vitamin C formulations;Bioavailability of vitamin C compared between six different formulations.;Excretion of vitamin C in urine over a 24 h period compared between six different formulations.;Uptake and maintenance of vitamin C in peripheral blood mononuclear cells (PBMCs) between six different formulations.