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Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01133496
First received: May 27, 2010
Last updated: June 11, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck & Co.


Condition Intervention Phase
Healthy
 Drug: Alendronate Sodium Tablets, 70 mg
 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: Open Label, Balanced, Randomized, Two-way, Single-dose, Crossover Bioequivalence Study of Alendronate Sodium 70 mg Tablets of Dr Reddy's, India and Fosamax® Tablets of Merck & Co., Inc., USA, in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate Sodium
Alendronate Sodium Tablets, 70 mg of Dr. Reddy's
 Drug: Alendronate Sodium Tablets, 70 mg
Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.
Other Name: Fosamax Tablets 70 mg
Active Comparator: Fosamax
Fosamax Tablets 70 mg of Merck & Company. Inc., USA.
 Drug: Alendronate Sodium Tablets, 70 mg
Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.
Other Name: Fosamax Tablets 70 mg

Detailed Description:

Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's Laboratories Limited, India and Fosamax® tablets of Merck & Co., Inc., USA, in healthy, adult, human subjects under fasting conditions.

  Eligibility

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

Inclusion Criteria:

  1. Healthy human subjects aged between 18 and 45 years (including both).
  2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 but weight not less than 45 Kgs.
  3. Female subjects who are postmenopausal or surgically sterile.
  4. 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.
  5. Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations and serology tests.
  6. Subjects having normal 12-lead electrocardiogram (ECG).
  7. Subjects having normal chest X-Ray (P/A view).
  8. Subjects able to communicate effectively.
  9. Subjects willing to given written informed consent and adhere to all the requirements of this protocol.

Exclusion Criteria:

  1. Subjects having contraindications or hypersensitivity to Alendronate sodium or related drugs.
  2. History or presence of any medical condition or disease according the opinion of the physician.
  3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  4. History or presence of significant alcoholism or drug abuse in the past one year.
  5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day or consumption of tobacco products).
  6. Difficulty with donating blood.
  7. Difficulty in swallowing solids like tablets or capsules.
  8. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
  9. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  10. Pulse rate less than 50/minute or more than 100/minute.
  11. Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing.
  12. Major illness during 3 months before screening.
  13. Participation in a drug research study within past 3 months.
  14. Donation of blood in the past 3 months before screening.
  15. Female volunteers demonstrating a positive pregnancy screen.
  16. Female volunteers who are currently breast-feeding.
  17. Female volunteers with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133496

Locations
India
GVK Biosciences Pvt. Ltd.,
Hyderabad, Andhra Pradesh, India, 500038
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Naba Kr Talukdar, MD GVK Biosciences Pvt. Ltd.
  More Information

No publications provided

Responsible Party: Mr. Indu Bhushan/Senior Director - R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01133496     History of Changes
Other Study ID Numbers: 095-06
Study First Received: May 27, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Alendronate Sodium
crossover

Additional relevant MeSH terms:
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013