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This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate sodium tablets 150 mg | Experimental | Ibandronate sodium tablets 150 mg of Dr. Reddy's Laboratories Limited |
|
| Boniva | Active Comparator | Boniva Tablets 150 mg of Roche Laboratories Inc, USA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate sodium | Drug | Ibandronate sodium Tablets 150 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve(AUC) | 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. |
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Inclusion Criteria:
The subjects should be healthy human of 18 years or older.
The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
The subjects should have a BMI between 19 and 30 weight in kg/ height2 in meter.
The subjects should be able to communicate effectively with study personnel.
The subjects should be able to give written informed consent to participate in the study.
If subject is a female volunteer and
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
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) or
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Simran Sethi, MBBS | BA Research India Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BA Research India Ltd | Ahmedabad | Gujarat | 380 054 | India |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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