Status:
COMPLETED
Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Osteoporosis
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief 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. Addition...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Subjects were included based on the following criteria:
- males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects
- body mass index between 19 and 24 kg/m2
- thorax radiography and ECG with no abnormalities
- normal blood pressure values
- heart rate
- laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis)
- negative test results for HIV and hepatitis B.
Exclusion
- Subjects were excluded if they had a heart disease or disorder
- A hepatic, renal, respiratory, immune system, or nervous system disorder
- Any of the following conditions:
- pregnancy
- breast-feeding
- hypocalcemia
- prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study
- blood donation or participation in other clinical trials within 3 months before enrollment in the study
- alcohol or drug abuse
- smoking more than 10 a day
- clinically significant allergies to drugs or foods
- sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
- A ventricular rate \<60 beats/min or \>100 beats/min at rest.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02295436
Start Date
August 1 2014
End Date
October 1 2014
Last Update
November 20 2014
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