Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioavailability
Intervention: Risedronate (Drug); Risedronate (Drug); Risedronate (Drug); Risedronate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s): William S Aronstein, MD, PhD, Study Director, Affiliation: Procter and Gamble
Summary
This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study.
Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and
have urine collected over 72 hours following administration of risedronate for all 4
treatment periods).
Clinical Details
Official title: Influence of a High-fat Meal on the Bioavailability of a Two Different Formulations of Risedronate
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Assess the relative bioavailability of the 35 mg DR risedronate tablet administered immediately after a high-fat meal compared to the 35 mg IR risedronate tablet administered 30 minutes prior to a high-fat meal.
Secondary outcome: Assess the relative bioavailability of a 35 mg DR risedronate tablet administered immediately after a high-fat meal compared to the same 35 mg DR risedronate tablet administered under fasted conditions.
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Females 40 - 70 years at time of first dose
- BMI less than or equal to 32 kg/square meter
- Non-lactating and either surgically sterile or postmenopausal
Exclusion Criteria:
- Clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid
disease
- Had a major surgical operation requiring inpatient hospitalization within 1 month
prior to screening or plans to have a major surgical operation during the course of
the study
- A history of cancer within the past 5 years, except for basal cell carcinoma with
documentation of a 6-month remission at screening. Subjects with a more recent
history of successfully treated cervical carcinoma in situ will not be excluded,
provided there is documentation of a 12-month remission
- Any disease or surgery known to alter normal gastrointestinal structure or function
- A history of gastrointestinal disease (peptic ulceration, gastrointestinal bleeding,
ulcerative colitis, Crohn's disease, irritable bowel syndrome, or moderate to severe
gastro-esophageal reflux disease that requires prescription or frequent [> 3
times/week] nonprescription medicinal intervention [eg, antacids])
- A history of gastrointestinal surgery, with the exception of appendectomy and hernia
repair that did not require bowel resection (subjects who have undergone appendectomy
or hernia repair within the 12 months prior to screening will be excluded from the
study)
- Acute gastritis, diarrhea or constipation within the 14-day period prior to the
predicted first dosing day. If screening occurs >14 days before the first dosing day,
subjects will be re-evaluated for eligibility at admission. Diarrhea will be defined
as the passage of liquid feces and/or a stool frequency of greater than 3 times per
day. Constipation will be defined as having less than 3 bowel movements per week or
as having fewer bowel movements than is usual for the subject
Exclusion at Admission:
- Any significant change from screening which in the investigator's opinion would
impact safety of subject or interfere with the evaluation of the study drug.
- Had any acute illness within the past 2 weeks.
- Consumed alcohol, grapefruit or grapefruit juice, orange juice, chocolate, or
caffeine within 72 hours of dosing.
- Used a bisphosphonate since screening.
- Reported exposure to any known enzyme inducer or inhibitor, transport induceror
inhibitor or nonmedical enzyme-inducers such as paint solvents or pesticides since
screening.
- A positive pregnancy test.
Locations and Contacts
Research Site, Ft Myers, Florida, United States
Research Site, Miramar, Florida, United States
Research Site, Austin, Texas, United States
Additional Information
Starting date: November 2007
Last updated: October 7, 2011
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