Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor safety of subjects
Open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose comparative oral bioavailability study in healthy, adult, human subjects under fed conditions
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine Delayed-Release Capsules, 60 mg | Experimental | Duloxetine Delayed-Release Capsules, 60 mg of Dr. Reddys Laboratories Limited |
|
| Cymbalta | Active Comparator | Cymbalta® 60 mg capsule of Eli Lilly and Company |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Duloxetine Delayed-Release Capsules 60 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) | 1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose |
Not provided
Not provided
Inclusion Criteria:
The subjects should be healthy human between 18 and 45 years.
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 18.5 and 24.9 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.
Is postmenopausal for at least 1 year.
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr.Ronak Modi, MBBS | BA Research India Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BA Research India Ltd | Ahmedabad | Gujarat | 380 054 | India |
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cymbalta® | Drug | 60 mg capsule of Eli Lilly and Company |
|
| D006571 |
| Heterocyclic Compounds |