Poster Topical Area: Dietary Bioactive Components

Location: Hall D

Poster Board Number: 287

P08-029 - Bioequivalence Study on Vitamin C Gummy and Caplet in Healthy Adults

Monday, Jun 11
8:00 AM – 3:00 PM

Objective

Evaluate bioequivalence of Vitamin C gummy and a comparator Vitamin C caplet in healthy adults.

Methods

The design was a randomized examiner-blind comparator controlled cross-over study with two sequences separated by a 7-day washout. Healthy male or female adults 18-55 years of age, BMI 18.5-29.5 kg/m2 were enrolled. Intake of citrus foods and foods and beverages fortified with Vitamin C was restricted 7 days prior to each dosing. Participants were randomized into two interventions: VitafusionTM Power C gummy (1000 mg) or Nature Made Vitamin C caplet (1000 mg). Blood samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24h post-dose for plasma and white blood cell (WBC) and urine was collected pre-dose and between 0-2, 2-4, 4-8, 8-12 and 12-24 h post dose for L-ascorbic acid analysis. Safety measurements included vital signs, hematology and clinical chemistry. Subjects provided 7-day food records to ensure compliance to a low Vitamin C meal plan. Standardized meals were provided on in-clinic days. Statistical methods included a repeated measures ANOVA.

Results

A total of 30 subjects (9 Males, 21 females) mean age 34.0 ± 11.4 years and mean BMI 24.5 ± 3.6 kg/m2 completed the study. There were no clinically relevant adverse events and safety parameters remained within normal clinical range for both products. Both gummy and caplet demonstrated similar plasma absorption profiles. There were no statistically significant differences between gummy and caplet in plasma L-ascorbic acid total AUC0-24, and Tmax. Although the caplet elicited a significantly higher Cmax than the gummy (p<0.05), the difference in Cmax for gummy and caplet was numerically small. WBC L-ascorbic acid total AUC0-24 and Cmax were not significantly different between gummy and caplet. Urine levels of L-ascorbic acid were not significantly different between gummy and caplet at any measured time point.

Conclusions

Under the conditions of this study, both gummy and caplet exhibited similar bioavailability and were therefore considered as bioequivalent. This study supports the gummy as a viable alternative to the caplet for providing Vitamin C nutrient.




Funding Source: Church & Dwight Co., Inc., Ewing, NJ.

CoAuthors: Malkanthi Evans – KGK Science Inc.; Janaki Iyer – KGK Science; Mohammed Marzuk – KGK Science Inc.; Kelly Zhang – Church & Dwight; William Hooper – Church & Dwight; Annahita Ghassemi – Church & Dwight

Najla Guthrie

President and Chief Operating Officer
KGK Science Inc
London, Ontario, Canada