Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.

NCT ID: NCT02962310

Last Updated: 2016-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-11-30

Brief Summary

Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

Detailed Description

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in Healthy Human Volunteers Under Fasting Condition.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets 40 mg

Group Type: EXPERIMENTAL

Torrent's Rosuvastatin Calcium Tablets 40 mg

Intervention Type: DRUG

oral, crossover

Reference

Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA

Group Type: ACTIVE_COMPARATOR

Crestor 40 mg Tablets of AstraZeneca LP, USA

Intervention Type: DRUG

oral, crossover

Interventions

Torrent's Rosuvastatin Calcium Tablets 40 mg

oral, crossover

Intervention Type: DRUG

Crestor 40 mg Tablets of AstraZeneca LP, USA

oral, crossover

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Torrent Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PK-09-045

Identifier Type: -

Identifier Source: org_study_id