NCT01627886

Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition

Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India and 'BONIVA®' 150 mg (Ibandronate Sodium) Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.

Detailed description

Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India And 'BONIVA®' 150 mg (Ibandronate Sodium)Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions (With As Many Postmenopausal Women As Possible).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ibandronate sodium	Ibandronate sodium Tablets 150 mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2012-06-26
• Last updated: 2012-06-28

Locations

1 site across 1 country: India