Clinical Trials Logo

Clinical Trial Summary

The primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.


Clinical Trial Description

This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT02295436
Study type Interventional
Source Wuhan Union Hospital, China
Contact
Status Completed
Phase Phase 1
Start date August 2014
Completion date October 2014

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Completed NCT03822078 - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women Phase 1
Recruiting NCT05845021 - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Completed NCT04736693 - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Completed NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Completed NCT02143674 - Muscle Strengthening Exercises and Global Stretching in Elderly N/A
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A