NCT02296762

Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition

Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Sirolimus Tablets 2 mg Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions.

Detailed description

Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Sirolimus tablets 2 mg under Fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sirolimus	Sirolimus tablets 2 mg

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2014-11-20
• Last updated: 2014-11-20

Locations

1 site across 1 country: India