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Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694797
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions

Condition or disease Intervention/treatment Phase
Healthy Drug: Metoprolol Succinate Phase 1

Detailed Description:
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

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, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metoprolol Succinate Extended-Release Tablets 50 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of TOPROL-XL® (Containing Metoprolol Succinate) Extended-Release Tablets 50 mg of AstraZeneca LP Wilmington, DE in Healthy, Adult, Human Subjects Under Fasting Conditions
Study Start Date : January 2011
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metoprolol Succinate ER Tablets, 50 mg
Metoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd
Drug: Metoprolol Succinate
Other Name: TOPROL-XL®
Active Comparator: TOPROL-XL ER Tablets 50 mg
TOPROL-XL ER Tablets 50 mg of AstraZeneca
Drug: Metoprolol Succinate
Other Name: TOPROL-XL®

Primary Outcome Measures :
  1. Area under curve (AUC) [ Time Frame: Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose. ]

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

Inclusion Criteria:

Subjects were selected based on the following inclusion criteria:

  • Provide written informed consent.
  • Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg.
  • Having a body mass index between 18.5 and 24.9 (both inclusive),calculated as weight in Kg/height in m2
  • Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study.(Laboratory values must be within normal limits or considered by the physician/investigator to be of no clinical significance).
  • Female Subjects 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.
  • surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

The subjects were excluded based on the following criteria during screening and during the study:

  • Incapable of understanding the informed consent.
  • Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
  • Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
  • Oral temperature is below 95.0°F or above 98.6°F.
  • Pulse rate below 50/min or above 100/min.
  • History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
  • Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  • Consumption of grapefruit for the past ten days prior to the check-in, in each period.
  • Habit of tobacco chewing.
  • Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
  • Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
  • Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
  • Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
  • Clinically significant abnormalities and lor with significant diseases.
  • Confirmed positive in alcohol screening.
  • Confirmed positive in selected drug of abuse.
  • Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
  • Confirmed positive in urine pregnancy test.
  • Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694797

Bioserve Clinical Research Private Limited
Hyderabad, Andhra Pradesh, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Dr. P. Vijaya Lakshmi, Clinical Investigator Bioserve Clinical Research Private Limited

Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT01694797     History of Changes
Other Study ID Numbers: 642/09
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: November 2010

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action