Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01627886
First received: June 22, 2012
Last updated: June 27, 2012
Last verified: November 2008
  Purpose

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.


Condition Intervention Phase
Healthy
Drug: Ibandronate sodium
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-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India and 'BONIVA®' 150 mg (Ibandronate Sodium) Tablets Of Roche Laboratories Inc., USA 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: Prior to dosing (0.0 hour) and at 0.25, 0.50, 0.75, 1.0, 1.25, 1.50, 2.0, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours post dose. ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibandronate sodium tablets 150 mg
Ibandronate sodium tablets 150 mg of Dr. Reddy's Laboratories Limited
Drug: Ibandronate sodium
Ibandronate sodium Tablets 150 mg
Other Name: Boniva
Active Comparator: Boniva
Boniva Tablets 150 mg of Roche Laboratories Inc, USA
Drug: Ibandronate sodium
Ibandronate sodium Tablets 150 mg
Other Name: Boniva

Detailed Description:

Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India And 'BONIVA®' 150 mg (Ibandronate Sodium)Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions (With As Many Postmenopausal Women As Possible).

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subjects should be healthy human of 18 years or older.
  2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
  3. The subjects should have a BMI between 19 and 30 weight in kg/ height2 in meter.
  4. The subjects should be able to communicate effectively with study personnel.
  5. The subjects should be able to give written informed consent to participate in the study.

    If subject is a female volunteer and

  6. 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
  7. Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) or
  8. Should be postmenopausal healthy women who have attained complete menopause and have not had menstruation for at least one year and are not on hormone replacement therapy.
  9. Should have 17ß-estradiol serum levels of ≤92 pmol/L, follicle stimulating hormone (FSH) of ≥40 IU/L during the screening (only for postmenopausal healthy women)

Exclusion Criteria:

  1. The subjects who have a history of allergic responses to Ibandronate or other related drugs.
  2. The subjects who have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, X-ray and vaginal ultrasonography recordings (only for female subjects)]
  3. The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
  4. The subjects who have a history or presence of bronchial asthma.
  5. The subject who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
  6. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
  7. The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who can not refrain from smoking during study period.
  8. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
  9. The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
  10. The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
  11. The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
  12. The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.
  13. Female volunteers demonstrating a positive pregnancy screen.
  14. Female volunteers who are currently breast-feeding.
  15. Female volunteers not willing to use contraception 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: NCT01627886

Locations
India
BA Research India Ltd
Ahmedabad, Gujarat, India, 380 054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Simran Sethi, MBBS BA Research India Ltd
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01627886     History of Changes
Other Study ID Numbers: BA0859144-01
Study First Received: June 22, 2012
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014