Back to resultsBioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fed Condition
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Torrent's Felodipine Extended-Release Tablets
Sponsored by
About this trial
This is an interventional trial for Healthy
Eligibility Criteria
Inclusion Criteria:
The volunteers were included in the study based on the following criteria:
- Sex: male.
- Age: 18 - 45 years.
- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
Pulse rate less than 50/minute or more than 100/minute.
- Oral temperature less than 95°P or more than 98.6°P.
- Respiratory rate less than 12/minute or more than 20/minute
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- History of alcohol or drug abuse
- Positive breath alcohol test
- Recent history of kidney or liver dysfunction.
- History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of heart failure.
- HIV, HCV, HBsAg positive volunteers.
- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
- Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- Administration of any study drug in the period 0 to 3 months before entry to the study.
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- History of pre-existing bleeding disorder.
- Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
- Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Sites / Locations
- Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.
Outcomes
Primary Outcome Measures
bioequivalence based on Composite of Pharmacokinetics
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
Secondary Outcome Measures
Full Information
NCT ID
NCT01630902
First Posted
June 26, 2012
Last Updated
June 27, 2012
Sponsor
Torrent Pharmaceuticals Limited
1. Study Identification
Unique Protocol Identification Number
NCT01630902
Brief Title
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fed Condition
Official Title
An Open Label, Randomised, 2-period, 2-treatment, 2-sequence, Cross-over, Single-dose Bioequivalence Study of Felodipine Extended-Release Tablets USP 10 mg (Test, Torrent Pharmaceuticals Ltd., India) Versus Felodipine Extended-Release Tablets USP 10 mg (Reference, Mylan Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fed Condition
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torrent Pharmaceuticals Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective:
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 21 days during fasting study.
Study Design:
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Torrent's Felodipine Extended-Release Tablets
Primary Outcome Measure Information:
Title
bioequivalence based on Composite of Pharmacokinetics
Description
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The volunteers were included in the study based on the following criteria:
Sex: male.
Age: 18 - 45 years.
Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
Healthy and willing to participate in the study.
Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
Clinically relevant abnormalities in the results of the laboratory screening evaluation.
Clinically significant abnormal ECG or Chest X-ray.
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
Pulse rate less than 50/minute or more than 100/minute.
Oral temperature less than 95°P or more than 98.6°P.
Respiratory rate less than 12/minute or more than 20/minute
History of allergy to the test drug or any drug chemically similar to the drug under investigation.
History of alcohol or drug abuse
Positive breath alcohol test
Recent history of kidney or liver dysfunction.
History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
Volunteers suffering from any chronic illness such as arthritis, asthma etc.
History of heart failure.
HIV, HCV, HBsAg positive volunteers.
Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
Administration of any study drug in the period 0 to 3 months before entry to the study.
History of significant blood loss due to any reason, including blood donation in the past 3 months.
History of pre-existing bleeding disorder.
Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Facility Information:
Facility Name
Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.
City
Village Bhat, Gandhinagar
State/Province
Gujarat
Country
India
12. IPD Sharing Statement
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Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fed Condition
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