Back to resultsBioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Bioequivalence, Amlodipine Besylate
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects between 18 and 45 years of age inclusive.
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weigh at least 115 (Appendix I and Appendix II).
Exclusion Criteria:
- If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the three treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of themselves or their partners or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
- Hypersensitivity to amlodipine besylate (Norvasc®)or related calcium channel blockers).
- Any history of a clinical condition that might affect drug absorption, metabolism or excretion.
- Recent history of mental illness, drug addiction, drug abuse or alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or -herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
- Regular tobacco use in the 6 months prior to study dosing.
Sites / Locations
- AAI Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amlodipine Tablets, 10 mg
Norvasc Tablets, 10 mg
Arm Description
Amlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited
Outcomes
Primary Outcome Measures
Bioequivalence based on Cmax and AUC parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT01131936
First Posted
May 26, 2010
Last Updated
June 11, 2010
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01131936
Brief Title
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
Official Title
An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
November 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.
Detailed Description
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Bioequivalence, Amlodipine Besylate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amlodipine Tablets, 10 mg
Arm Type
Experimental
Arm Description
Amlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited
Arm Title
Norvasc Tablets, 10 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Norvasc 10 mg tablets of Pfizer, Inc.,
Intervention Description
Amlodipine Tablets, 10 mg
Primary Outcome Measure Information:
Title
Bioequivalence based on Cmax and AUC parameters
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects between 18 and 45 years of age inclusive.
Informed of the nature of the study and given written informed consent.
Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weigh at least 115 (Appendix I and Appendix II).
Exclusion Criteria:
If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the three treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of themselves or their partners or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Hypersensitivity to amlodipine besylate (Norvasc®)or related calcium channel blockers).
Any history of a clinical condition that might affect drug absorption, metabolism or excretion.
Recent history of mental illness, drug addiction, drug abuse or alcoholism.
Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
Received an investigational drug within the 4 weeks prior to study dosing.
Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or -herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
Regular tobacco use in the 6 months prior to study dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Scallion EE, MD
Organizational Affiliation
AAI Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
AAI Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
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Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
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