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Completed

NCT Number: NCT00755872

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

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).

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Fort Myers, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

risedronate

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

  • Sanofi

Registry information

Official study title

Influence of a High-fat Meal on the Bioavailability of a Two Different Formulations of Risedronate

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2008
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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