Dose Linearity Study of Codeine Sulfate Under Fasted Conditions

Roxane Laboratories

Status and phase

Completed

Phase 1

Conditions

Pain

Treatments

Drug: Codeine Sulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01009697

CODE-T15/30/60-PVFS-1

Details and patient eligibility

About

The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions

Enrollment

34 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.