To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Desipramine HCl 50 mg Tablets Cord Laboratories; Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914004

8718-D

Details and patient eligibility

About

To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 40 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)

---

36 participants in 2 patient groups

1

Experimental group

Description:

Desipramine HCl 50 mg Tablets Cord Laboratories

Treatment:

Drug: Desipramine HCl 50 mg Tablets Cord Laboratories

2

Active Comparator group

Description:

Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc

Treatment:

Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc