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

NCT03761979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-03

No results posted yet for this study

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.

Conditions

  • Low Bone Density
  • Osteopenia
  • Osteoporosis, Postmenopausal

Interventions

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.

Sponsors & Collaborators

  • Biofortis Innovation Services

    collaborator INDUSTRY

  • NMS Laboratories

    collaborator UNKNOWN

  • BioLink Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kristin Sanoshy · Biofortis Innovation Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2017-06-01
Completion
2017-07-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761979 on ClinicalTrials.gov