Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Ibandronate sodium (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Dr. Simran Sethi, MBBS, Principal Investigator, Affiliation: BA Research India Ltd
Summary
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,
crossover, oral bioequivalence study.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under curve(AUC)
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
Minimum age: 19 Years.
Maximum age: 64 Years.
Gender(s): Both.
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.
Locations and Contacts
BA Research India Ltd, Ahmedabad, Gujarat 380 054, India
Additional Information
Starting date: September 2008
Last updated: June 27, 2012
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