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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01694797
First received: September 24, 2012
Last updated: September 27, 2012
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Metoprolol Succinate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2011
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694797

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

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01694797     History of Changes
Other Study ID Numbers: 642/09
Study First Received: September 24, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on July 22, 2014