Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food

Warner Chilcott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 35 mg risedronate DR tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868907

2008138

Details and patient eligibility

About

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

Enrollment: 101 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female, 40 to 70 years of age
• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

101 participants in 3 patient groups

Treatment A

Experimental group

Description:

35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet

Treatment:

Drug: 35 mg risedronate DR tablet

Drug: 35 mg risedronate DR tablet

Drug: 35 mg risedronate DR tablet

Treatment B

Experimental group

Description:

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner

Treatment:

Drug: 35 mg risedronate DR tablet

Drug: 35 mg risedronate DR tablet

Drug: 35 mg risedronate DR tablet

Treatment C

Active Comparator group

Description:

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Treatment:

Drug: 35 mg risedronate DR tablet

Drug: 35 mg risedronate DR tablet

Drug: 35 mg risedronate DR tablet