title: Evaluation of D-ribose pharmacokinetics, dose proportionality, food effect, and pharmacodynamics after oral solution administration in healthy male and female subjects.
abstract: This was a double blind, randomized, crossover study of three periods evaluating pharmacokinetics and pharmacodynamics in 12 healthy, adult subjects after administration of D-ribose powder for oral solution, 2.5, 5.0, and 10.0 g, under fasting conditions followed by an open label, randomized, fourth period assessing the effect of food on the pharmacokinetics of D- ribose (10.0 g) under fed conditions with either a high fat (HF, N = 6) or high carbohydrate (HC, N = 6) meal. D-ribose was absorbed rapidly with mean Tmax ranging between 18 and 30 minutes. Cmax and AUC increased more than proportionally with dose indicating increased absorption and saturation of metabolism. When D-ribose was administered with meals, Tmax was unchanged; however, Cmax and AUC decreased by 42.6% and 40.8%, respectively with HF and 69.1% and 64.9%, respectively with HC. The amount of D-ribose in urine ranged from 4.15% to 7.20% of the administered dose. Dose-related decreases in serum glucose up to 26.3 mg/dL (30.3% of baseline) occurred in the first 60 minutes post dose and insulin response attained a dose-related peak 15 minutes post dose. D-ribose was generally safe and well tolerated in the dose range studied.
authors.affiliation: RiboCor, Inc., 7077 Northland Circle North, Suite 100, Minneapolis, MN, 55428, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Thompson
authors.affiliation: Orange County Research Center, 14351 Myford Road, Suite B, Tustin, CA, 92780, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Neutel
authors.affiliation: Integrium, LLC, 100 E. Hanover Avenue, Suite 401, Cedar Knolls, NJ, 07927, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Homer
authors.affiliation: KTC, Inc., 1901 Lake Road, Wayzata, MN, 55391, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Tempero
authors.affiliation: Ajit Pharma LLC, 9671 LaForet Drive, Eden Prairie, MN, 55347, USA.
authors.forename: Ajit
authors.initials: A
authors.lastname: Shah
authors.affiliation: RiboCor, Inc., 7077 Northland Circle North, Suite 100, Minneapolis, MN, 55428, USA.
authors.forename: Raj
authors.initials: R
authors.lastname: Khankari
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D018592:Cross-Over Studies; D004040:Dietary Carbohydrates / Q000494:pharmacology*; D004041:Dietary Fats / Q000494:pharmacology*; D004311:Double-Blind Method; D005215:Fasting / Q000378:metabolism; D005260:Female; D018565:Food-Drug Interactions; D064368:Healthy Volunteers; D006801:Humans; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged; D012266:Ribose / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D012996:Solutions; D014527:Uric Acid / Q000097:blood; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D004040:Dietary Carbohydrates; D004041:Dietary Fats; D007328:Insulin; D012996:Solutions; D014527:Uric Acid; D012266:Ribose
keywords: D‐ribose; dose proportionality; food effect; pharmacodynamics; pharmacokinetics