Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions

NCT01645384 | Completed Phase 1 DMC

• 1 other identifier: 01621/09-10
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Atorvastatin calcium; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  Pre-dose at 0.00, 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 hours and 48.00 hours post dose.

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 mg DRUG

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

Also known as: Lipitor® 40 mg Tablets

Atorvastatin Calcium Tablets, 40 mg; Lipitor® 40 mg Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• He/She should provide written informed consent.
• He/She must be a healthy adult within 18-45 years of age (inclusive).
• He/She should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
• He/She should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg. Similarly diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
• He/She must be of normal health as determined by medical history and physical examination performed within 21 days prior to the dosing of period 1.
• He/She should have a normal ECG, chest X-ray and vital signs.
• Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence. or is postmenopausal for at least 1 year. or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study volunteers)

You may not qualify if:

• He/She is incapable of understanding the informed consent.
• He/She has a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
• He/She has any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy,asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
• He/She smokes regularly more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
• He/She has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to dosing in first period.
• He/She has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
• He/She has a history of alcohol or substance abuse within the last 5 years.
• He/She has clinically significant abnormal values of laboratory parameters.
• He/She has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
• He/She is unable to or likely to be non-compliant with protocol requirements or restrictions.
• He/She, in whom study drug is contraindicated for medical reasons
• He/She is intolerant to venipuncture.
• Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
• Female volunteer demonstrates a positive pregnancy screen. Each female study volunteer will be screened for pregnancy at screening, check-in each study period. Study volunteer with a positive or inconclusive result will be withdrawn from the study.
• Female volunteer is currently breast feeding. Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study will not be allowed to participate. Female study volunteer of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or she will not be allowed to participate.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Vimta Labs Limited

Hyderabad, Andhra Pradesh, 500 051, India

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Dr. Sudarshan Vishwanath, MD

  Vimta Labs Limited

  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: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

IN (1)