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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002360 |
The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI.
Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may replace the need for antacids.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Didanosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study |
Official Title: | Pivotal Bioequivalence Study of Videx Chewable/Dispersible Buffered Tablets and an Encapsulated Enteric Coated Bead Formulation of Didanosine in HIV-Infected Subjects |
Estimated Enrollment: | 30 |
Study Start Date: | March 1999 |
Estimated Study Completion Date: | March 1999 |
Didanosine, a purine nucleoside analogue, is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Didanosine is administered orally with antacids to protect it against acid-induced hydrolysis in the stomach. To eliminate the need for using buffers in the ddI formulations, an enteric-coated bead formulation of ddI is being developed.
Patients are randomized to 1 of 2 groups to receive treatment on 2 separate occasions at least 72 hours apart. Group 1 receives the reference formulation of ddI. Group 2 receives the test formulation of ddI. Clinical evaluations, including clinical laboratory tests, are performed periodically during the study and at discharge. Serial blood samples are collected at specific time points over the 12 hours following dosing, and are used for the pharmacokinetic variables CMAX and AUC(INF). Factors used in analysis are sequence, subject within sequence, period, and formulation. Safety is assessed by monitoring adverse effects, vital signs, ECG recordings, and clinical laboratory tests throughout the study.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Study ID Numbers: | 039H, 31876, AI454-157 |
Study First Received: | November 2, 1999 |
Last Updated: | August 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00002360 |
Health Authority: | United States: Food and Drug Administration |
Didanosine Tablets Reverse Transcriptase Inhibitors Anti-HIV Agents Therapeutic Equivalency |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |