- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01645449
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions
July 19, 2012 updated by: Dr. Reddy's Laboratories Limited
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-way Crossover Oral BE Study of Atorvastatin Ca 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer in Healthy Adult, Human Subjects Under Fasting Conditions
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An open label, balanced, randomized, two-treatment, two-period, two-way crossover oral bioequivalence' study of Atorvastatin Calcium 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy adult, human subjects under fasting conditions.
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Neu-Ulm, Germany, 89231
- Nuvisan Pharma Services GmbH & Co. KG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects aged 18 - 55 (including) years old.
- Subjects' weight within normal range according to normal values for Body Mass Index (1 8.0 to 30.0 kg/m2) with minimum of 50 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable range.
- Subjects having normal 12-lead electrocardiogram (ECG).
- systolic blood pressure between 90 mmHg to 145 mmHg (age 18 to 45 years) or 90 mmHg to 160 mmHg (above 45 years). Diastolic blood pressure between 50 mrnHg to 90 rnmHg. Pulse rate between 45 bpm and 100 bpm.
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and morphine).
- Subjects having negative alcohol breath test.
- Women who are of childbearing potential must be using acceptable methods of birth control for 4 weeks prior to, during and 4 weeks after the last dose of trial medication and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical research trial. Accepted forms of contraception are: i.e. implants, injectables, hormonal intrauterine device, combined oral contraceptives, sexual abstinence and vasectomised sexual partner throughout the trial. Female volunteers who are post-menopausal, hysterectomised or surgically sterile may be enrolled.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
Exclusion Criteria:
The subjects were excluded from the study, if they met any of the following criteria:
- Hypersensitivity to the test, or reference drug, or all other used ingredients, or related class of drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological,neurological or psychiatric disease or disorder.
- Individual or farniliy case medical history of any myopathy.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month before first dosing in Period 1.
- Medical history of muscular toxic reactions during treatment with statins of fibrates.
- Use of any prescribed or OTC medication or herbal supplements within 14 days or within 5 times the half-life of the respective active substance (whatever is longer), before first dosing in Period 1 (excluding contraceptives on women).
- History or presence of significant alcoholism or drug abuse in the past one year. Alcoholism is defined as consumption of more than 50g of ethanol per day (12.5 cL glass of 10° [l0%]] wine = 12 g; 4 cL of aperitif, 42° [42 %] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g.
- History or presence of significant smoking (more than 10 cigarettes/day).
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric andlor duodenal ulceration.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Major illness during 3 months before first dosing in Period 1.
- Participation in a drug research study within the past 1 month before first dosing in Period 1.
- Donation of blood in the past 2 months before first dosing in Period 1.
- Consumption of grapefruit juice, xanthine-containing products or alcohol for within 48 hours prior to dosing.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Pregnancy or breast-feeding (for female subjects).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atorvastatin Calcium Tablets, 80 mg
Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Laboratories Limited
|
Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Other Names:
|
Active Comparator: Lipitor 80 mg Tablets
Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals
|
Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under curve (AUC)
Time Frame: Pre-dose at 0.00 hour and post-dose at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00,6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours
|
Pre-dose at 0.00 hour and post-dose at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00,6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. med. Margarete Muller, Nuvisan Pharma Services GmbH & Co. KG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
July 18, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
July 20, 2012
Last Update Submitted That Met QC Criteria
July 19, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-VIN-095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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