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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02292069 |
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Date of registration:
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12/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
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Scientific title:
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Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fed Condition |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02292069 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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India
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Contacts
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Name:
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Dr.Gunjan Shah, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Veeda Clinical Research Pvt. Ltd |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Amlodipine besylate/Atorvastatin calcium
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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10-VIN-107
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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