Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00717145

Enrollment

Registered

2008-07-16

Start date

2008-07-31

Completion date

2008-09-30

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-lactating, Postmenopausal, Surgically Sterile

Keywords

bioequivalence

Brief summary

Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.

Interventions

DRUGrisedronate

one risedronate 20 mg DR tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* non-lactating and either surgically sterile or postmenopausal: * body mass index less than or equal to 32 kg/m2 at screening

Exclusion criteria

* No use of a bisphosphonate within 1 month * no history of GI disease * no use of any medications within 7-14 days prior to scheduled dosing day

Design outcomes

Primary

Measure	Time frame
Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal.	4 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026