To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.); Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946764

AA28312

Details and patient eligibility

About

To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.

Enrollment: 48 patients

Sex: All

Ages: 19 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

1

Experimental group

Description:

Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)

Treatment:

Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)

2

Active Comparator group

Description:

Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

Treatment:

Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)