NCT01630902CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 1
- Primary Endpoint
- bioequivalence based on Composite of Pharmacokinetics
Study Overview
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
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting ConditionHealthyNCT01630655Torrent Pharmaceuticals Limited
Completed
Phase 1
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fasted ConditionsHealthyNCT01928056Torrent Pharmaceuticals Limited
Completed
Phase 1
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fed ConditionsHealthyNCT01990586Torrent Pharmaceuticals Limited
Completed
Phase 1
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fed ConditionHealthyNCT01996501Torrent Pharmaceuticals Limited
Completed
Phase 1
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed ConditionsHealthyNCT01928069Torrent Pharmaceuticals Limited