Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition
- Registration Number
- NCT01996462
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Objective:
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg \[Test formulation, Torrent Pharmaceuticals Ltd., India\] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) \[Reference formulation, Forest Laboratories Inc, USA\] . Dosing periods were separated by a washout period during fasted study.
Study Design:
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Torrent's of Escitalopram Oxalate Tablet 20 mg Escitalopram Oxalate Tablets -
- Primary Outcome Measures
Name Time Method bioequivalence based on Composite of Pharmacokinetics plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration 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
Name Time Method
Trial Locations
- Locations (1)
Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.
🇮🇳Village Bhat, Gandhinagar, Gujarat, India
Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.🇮🇳Village Bhat, Gandhinagar, Gujarat, India