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

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ClinicalTrials.gov Identifier: NCT02962323
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Torrent's Rosuvastatin Calcium Tablets 40 mg Drug: Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA Phase 1

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 Fed Condition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Test
Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets 40 mg
Drug: Torrent's Rosuvastatin Calcium Tablets 40 mg
Oral, crossover

Active Comparator: Reference
Crestor 40 mg of AstraZeneca Pharmaceuticals LP, USA
Drug: Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA
Oral, crossover




Primary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose to 96 hours post-dose ]
  2. AUC [ Time Frame: pre-dose to 96 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT02962323    
Other Study ID Numbers: PK-09-046
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Calcium, Dietary
Rosuvastatin Calcium
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors