Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00755872
Other study ID # 2007120
Secondary ID
Status Completed
Phase Phase 1
First received September 18, 2008
Last updated October 7, 2011
Start date November 2007
Est. completion date February 2008

Study information

Verified date October 2011
Source Warner Chilcott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
Risedronate
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.
Risedronate
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.
Risedronate
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.
Risedronate
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.

Locations

Country Name City State
United States Research Site Austin Texas
United States Research Site Ft Myers Florida
United States Research Site Miramar Florida

Sponsors (2)

Lead Sponsor Collaborator
Warner Chilcott Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 Days No
Secondary 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. 4 Days No
See also
  Status Clinical Trial Phase
Completed NCT06043739 - Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects Phase 1
Completed NCT02557139 - Bioavailability of Belumosudil (KD025) in Healthy Male Subjects Phase 1
Completed NCT02010944 - A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels Phase 1
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Not yet recruiting NCT01136551 - Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A N/A
Completed NCT04097808 - Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects N/A
Active, not recruiting NCT06098001 - Bioavailability Study of Hemp Phenolics N/A
Completed NCT01912144 - Absorption of Phenolic Acids From Coffee in Humans N/A
Completed NCT03915626 - Effect of Heat on Rivastigmine TDS Products Early Phase 1
Completed NCT01448772 - Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions Phase 1
Completed NCT01464450 - Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants Phase 1
Completed NCT01181973 - Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects Phase 1
Completed NCT00858767 - Arabic Gum-Absorption Study N/A
Completed NCT04113564 - Absolute Oral Bioavailability of Remimazolam Phase 1
Completed NCT04645394 - Bioavailability of Anthocyanins From Aronia Extract in Healthy Men - a Pilot Study N/A
Completed NCT03485885 - Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
Completed NCT05840848 - Effect of Iron and Zinc Supplementation on B-carotene Bioavailability in Healthy Males N/A
Completed NCT02986529 - A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects Phase 1
Completed NCT01789359 - Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding N/A
Completed NCT01638143 - Bio-equivalence Study N/A