NCT01133496

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
Last Updated

June 14, 2010

Status Verified

June 1, 2010

Enrollment Period

Same day

First QC Date

May 27, 2010

Last Update Submit

June 11, 2010

Conditions

Healthy

Keywords

BioequivalenceAlendronate Sodiumcrossover

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Cmax and AUC parameters

    5 months

Study Arms (2)

Alendronate Sodium

EXPERIMENTAL

Alendronate Sodium Tablets, 70 mg of Dr. Reddy's

Drug: Alendronate Sodium Tablets, 70 mg

Fosamax

ACTIVE COMPARATOR

Fosamax Tablets 70 mg of Merck \& Company. Inc., USA.

Drug: Alendronate Sodium Tablets, 70 mg

Interventions

Alendronate Sodium Tablets, 70 mgDRUG

Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.

Also known as: Fosamax Tablets 70 mg
Alendronate SodiumFosamax

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Subjects having contraindications or hypersensitivity to Alendronate sodium or related drugs.
  • History or presence of any medical condition or disease according the opinion of the physician.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  • History or presence of significant alcoholism or drug abuse in the past one year.
  • History or presence of significant smoking (more than 10 cigarettes or beedi's/day or consumption of tobacco products).
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
  • Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  • Pulse rate less than 50/minute or more than 100/minute.
  • Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing.
  • Major illness during 3 months before screening.
  • Participation in a drug research study within past 3 months.
  • Donation of blood in the past 3 months before screening.
  • Female volunteers demonstrating a positive pregnancy screen.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GVK Biosciences Pvt. Ltd.,

Hyderabad, Andhra Pradesh, 500038, India

Location

MeSH Terms

Interventions

Alendronate

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Dr. Naba Kr Talukdar, MD

    GVK Biosciences Pvt. Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

December 1, 2006

Primary Completion

December 1, 2006

Study Completion

April 1, 2007

Last Updated

June 14, 2010

Record last verified: 2010-06

Locations

IN(1)