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CompletedNCT00755872Updated Oct 12, 2011

Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate

A Phase 1 interventional study of Risedronate and Risedronate in Bioavailability, sponsored by Warner Chilcott. Completed at 3 sites in United States. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-10-12.

Sponsored by Warner Chilcott · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Bioavailability
03

In context

Lead sponsor

Warner Chilcott is the lead sponsor of 57 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    1

    Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.

    Drug: Risedronate

  • Experimental
    2

    Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.

    Drug: Risedronate

  • Experimental
    3

    Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.

    Drug: Risedronate

  • Experimental
    4

    Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.

    Drug: Risedronate

Interventions

  • DrugRisedronate

    Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.

  • DrugRisedronate

    Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.

  • DrugRisedronate

    Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.

  • DrugRisedronate

    Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 Days

Secondary outcomes

  1. 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.

    Time frame: 4 Days

07

Study locations

3 sites
  • Research Site
    Ft Myers, Florida, United States
  • Research Site
    Miramar, Florida, United States
  • Research Site
    Austin, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00755872
Lead sponsor
Warner Chilcott
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Sep 19, 2008
Start date
Nov 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Oct 12, 2011

Study contacts

William S Aronstein, MD, PhD
study director · Procter and Gamble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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