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

• ClinicalTrials.gov Identifier: NCT02292069
• Recruitment Status: Completed
• First Posted: November 17, 2014
• Last Update Posted: November 17, 2014
• Sponsor: Dr. Reddy's Laboratories Limited
• Information provided by (Responsible Party): Dr. Reddy's Laboratories Limited

Tracking Information

• First Submitted Date: November 12, 2014
• First Posted Date: November 17, 2014
• Last Update Posted Date: November 17, 2014
• Study Start Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 12, 2014): 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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: November 12, 2014): 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

Drug: Amlodipine besylate/Atorvastatin calcium

Amlodipine besylate/Atorvastatin calcium 10/80 mg

Other Name: Caduet

Study Arms

• Experimental: Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg
  Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited
  Intervention: Drug: Amlodipine besylate/Atorvastatin calcium
• Active Comparator: Caduet
  Caduet® 10/80 mg tablets of Pfizer, Ireland
  Intervention: Drug: Amlodipine besylate/Atorvastatin calcium

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 12, 2014): 90
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects aged between 18 and 45 years (both inclusive).
2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
4. Subjects having normal 12-lead electrocardiogram (ECG).
5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

1. Hypersensitivity to Amlodipine and Atorvastatin or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
4. History or presence of significant alcoholism or drug abuse.
5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
6. History or presence of asthma, urticaria or other significant allergic reactions.
7. History or presence of significant gastric and/or duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or capsules.
12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
13. Major illness during 3 months before screening.
14. Participation in a drug research study within past 3 months.
15. Donation of blood in the past 3 months before screening.
16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
18. History or presence of significant easy bruising or bleeding.
19. History or presence of significant recent trauma.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02292069
• Other Study ID Numbers: 10-VIN-107
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Reddy's Laboratories Limited
• Study Sponsor: Dr. Reddy's Laboratories Limited
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dr.Gunjan Shah, MD; Veeda Clinical Research Pvt. Ltd

• PRS Account: Dr. Reddy's Laboratories Limited
• Verification Date: December 2011