Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics
- Registration Number
- NCT02295436
- Lead Sponsor
- Wuhan Union Hospital, China
- 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. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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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.
-
Subjects were excluded if they had a heart disease or disorder
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A hepatic, renal, respiratory, immune system, or nervous system disorder
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1-mg group minodronic acid Twelve healthy young subjects were administered a single oral dose of 1 mg minodronic acid tablets at day 1 and then received repeated oral doses of minodronic acid (1 mg) once daily for 7 days (day 3 to day 9). 2-mg group minodronic acid Twelve healthy young subjects were administered a single oral dose of 2 mg minodronic acid tablets. 4-mg group minodronic acid Twelve healthy young subjects were administered a single oral dose of 4 mg minodronic acid tablets under fasting state at period 1.After a washout period of 8 days, they received the same dosage under fed conditions (administrated 30 minutes before high-fat breakfast). 1-mg elderly group minodronic acid Twelve healthy elderly subjects were administered a single oral dose of 1 mg minodronic acid tablets.
- Primary Outcome Measures
Name Time Method AUC two months the area under the concentration-time curve
Cmax two months the maximum observed plasma concentration and
- Secondary Outcome Measures
Name Time Method adverse events two months