Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Rosuvastatin Calcium Tablets Under Fed Conditions

Healthy Subjects Clinical Trial

Official title:

An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Rosuvastatin Ca Tab 40 mg [Torrent,India] Versus Crestor 40 mg Tab [ AstraZeneca Pharmaceuticals LP, USA] in Healthy Subjects-Fed Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962323
• Other study ID #: PK-09-046
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2016
• Last updated: November 9, 2016
• Start date: November 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 Fed Condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Torrent's Rosuvastatin Calcium Tablets 40 mg
Oral, crossover
• Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA
Oral, crossover

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		pre-dose to 96 hours post-dose	No
Primary	AUC		pre-dose to 96 hours post-dose	No