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The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

NCT01221727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-07

Study results available
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Summary

This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Denosumab

Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.

DRUG

Midazolam

All subjects will receive two oral dose administrations of midazolam.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-07-31
Completion
2011-07-31

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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 NCT01221727 on ClinicalTrials.gov