NCT01645410

Brief Summary

The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

July 18, 2012

Last Update Submit

July 19, 2012

Conditions

Healthy

Keywords

BioequivalenceAtorvastatin calciumcrossover

Outcome Measures

Primary Outcomes (1)

  • Area under curve (AUC)

    Pre-dose at 0.00 hour and post dose at 0.25, 0.50, 0.75,1.00, 1.25, 1.50, 1.75,2.00,2.25,2.50,2.75,3.00,3.33,3.67,4.00,4.50, 5.00, 6.00,8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours

Study Arms (2)

Atorvastatin Calcium Tablets, 40 mg

EXPERIMENTAL

Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited

Drug: Atorvastatin Calcium Tablets, 40 mg

Lipitor® 40 mg Tablets

ACTIVE COMPARATOR

Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals

Drug: Atorvastatin Calcium Tablets, 40 mg

Interventions

Atorvastatin Calcium Tablets, 40 mgDRUG

Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited

Also known as: Lipitor® 40 mg Tablets
Atorvastatin Calcium Tablets, 40 mgLipitor® 40 mg Tablets

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged between 18 and 45 years (both inclusive)
  • Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2)with minimum of 50 kg weight.
  • Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  • Subjects having normal 12-lead electrocardiogram (ECG).
  • Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
  • Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine)/
  • Subjects having negative alcohol breath test.
  • Subjects willing to adhere to the protocol requirements and to provide written informed consent.

You may not qualify if:

  • The subjects were excluded from the study, if they meet any of the following criteria:
  • Hypersensitivity to Atorvastatin or related class of drugs.
  • History of presence of significant cardiovascular, pulmonary, hepatic,renal, gastrointestinal, endocrine, immunological,dermatological, neurological or psychiatric disease or disorder.
  • Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
  • History or presence of significant alcoholism or drug abuse in the past one year.
  • History or presence of significant smoking (more than 10 cigarettes of beedi's/day).
  • History or presence of asthma, urticaria or other significant allergic reactions.
  • History or presence of significant gastric and/or duodenal ulceration.
  • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  • History or presence of cancer.
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
  • Major illness during 3 months before screening.
  • Participation in a drug research study within past 3 months.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veeda Clinical Research Pvt. Ltd.,

Ahmedabad, Gujarat, 380 015, India

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Dr. Dharmesh Domadia, MD

    Veeda Clinical Research Pvt. Ltd.,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

March 1, 2009

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

IN(1)