Trial record 21 of 3275 for:
Area Under Curve AND Healthy
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
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ClinicalTrials.gov Identifier: NCT02292069 |
Recruitment Status :
Completed
First Posted : November 17, 2014
Last Update Posted : November 17, 2014
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Sponsor:
Dr. Reddy's Laboratories Limited
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
Tracking Information | ||||
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First Submitted Date ICMJE | November 12, 2014 | |||
First Posted Date ICMJE | November 17, 2014 | |||
Last Update Posted Date | November 17, 2014 | |||
Study Start Date ICMJE | September 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Area under curve (AUC) [ Time Frame: The post dose samples of 4.0 mL were drawn at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours for Amlodipine assay ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Area under curve (AUC) [ Time Frame: post dose samples of 4.0mL were drawn at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours for Atorvastatin assay ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition | |||
Official Title ICMJE | Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fed Condition | |||
Brief 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, adult,human subjects under Fed conditions. | |||
Detailed Description | Open label, randomized, two-treatment, two-period, two-sequence, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fed conditions. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: Amlodipine besylate/Atorvastatin calcium
Amlodipine besylate/Atorvastatin calcium 10/80 mg
Other Name: Caduet
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
90 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | India | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02292069 | |||
Other Study ID Numbers ICMJE | 10-VIN-107 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Reddy's Laboratories Limited | |||
Study Sponsor ICMJE | Dr. Reddy's Laboratories Limited | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Dr. Reddy's Laboratories Limited | |||
Verification Date | December 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |