Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Warner Chilcott

Status and phase: Completed; Phase 1

Conditions: Postmenopausal; Non-lactating; Surgically Sterile

Treatments: Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717145

2008052

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

94 participants in 4 patient groups

1

Experimental group

Description:

One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate

2

Experimental group

Description:

One risedronate 20 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate

3

Experimental group

Description:

One risedronate 35 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate

4

Experimental group

Description:

One risedronate 35 mg IR tablet taken following an overnight fast, 30 minutes before ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate