NCT03761979

Safety and Pharmacokinetics of Orally Administered Strontium L-Lactate in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: BioLink Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

No clinical trials have evaluated strontium L-lactate (SrLac), the strontium salt of the L-enantiomer of lactic acid. Therefore, this clinical study was conducted to obtain general safety and pharmacokinetic (PK) information following acute oral intakes of three doses of SrLac by healthy adults. The data provided valuable comparisons with the pharmacokinetics of other strontium salts that are in clinical use and allowed determination of the dose of SrLac that will be useful for the management of bone health.neficial for the treatment of low bone density of osteoporosis and osteopenia.

Detailed description

Purpose: The aim of this clinical study was to obtain safety and pharmacokinetic information following acute oral intakes of three ascending doses of strontium L-lactate by healthy adults. Subjects and methods: Ten healthy men and women, mean age 43 ± 2 years, ingested one of three ascending doses of strontium L-lactate (SrLac) once per week for three weeks in succession. Fasting blood collections were performed pre-dose and 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose for determination of serum strontium at each interval.

Conditions

• Low Bone Density
• Osteopenia
• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Strontium L-lactate	The Study Product was a highly pure form of SrLac, the strontium salt of L-lactic acid. SrLac was manufactured in compliance with current Good Manufacturing Practices. SrLac was thoroughly tested and met rigorous purity specifications. It was free from contamination by D-lactic acid and trace metals known to harm human health.

Timeline

• Start date: 2017-03-09
• Primary completion: 2017-06-01
• Completion: 2017-07-17
• First posted: 2018-12-03
• Last updated: 2018-12-03

Locations

1 site across 1 country: United States