NCT02295046

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition

Open Label, Randomized, Two-treatment, Two-period, Two-sequence,Crossover, Single Dose, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in Healthy Male and Female Volunteers under Fasting conditions.

Detailed description

Open label, randomized, two-treatment, two-period, two-sequence, crossover, single dose, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine besylate/Atorvastatin calcium	Amlodipine besylate/Atorvastatin calcium 10/80 mg

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2014-11-19
• Last updated: 2014-11-19

Locations

1 site across 1 country: Germany