       Document 0623
 DOCN  M9610623
 TI    Substitution of didanosine sachets by chewable tablets: a
       pharmacokinetic study in patients with AIDS.
 DT    9601
 AU    Burger D; Meenhorst P; Mulder J; Henrichs J; Frissen J; Kroon F; ten
       Napel C; Koks K; Bult A; Beijnen J; Department of Pharmacy, Slotervaart
       Hospital, Amsterdam, The; Netherlands.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):163-8.
       Unique Identifier : AIDSLINE MED/96007278
 AB    We have conducted a pharmacokinetic study of didanosine (ddI),
       formulated in sachets and in tablets, in patients with acquired immune
       deficiency syndrome (AIDS). Fifteen subjects received 250 or 167 mg of
       ddI twice daily as the sachet formulation and used this for at least 1
       month. Subsequently, the patients were converted to receive ddI
       chewable/dispersible tablets (250-mg sachets to 200-mg tablets; 167-mg
       sachets to 125-mg tablets). Four subjects withdrew because of clinical
       deterioration or adverse effects. Serial blood samples were collected
       for pharmacokinetic monitoring during the use of the sachets and after 1
       month of use of the tablets. No statistically significant differences
       were found in the maximum plasma concentration (Cmax), the time to reach
       Cmax (tmax), the area under the plasma concentration-time curve (AUC),
       or the terminal elimination half-life (t1/2) between the two
       formulations. Patients who received low-dose ddI (sachets, 167 mg;
       tablets, 125 mg) displayed lower plasma concentrations than did the
       patients receiving high-dose ddI (sachets, 250 mg; tablets, 200 mg),
       despite an equal weight-normalized dose of ddI in these two groups.
 DE    Absorption  Acquired Immunodeficiency Syndrome/DRUG THERAPY/*METABOLISM
       Administration, Oral  Adult  Antiviral Agents/ADMINISTRATION &
       DOSAGE/*PHARMACOKINETICS/  THERAPEUTIC USE  Biological Availability
       Didanosine/ADMINISTRATION & DOSAGE/*PHARMACOKINETICS/THERAPEUTIC  USE
       Female  Half-Life  Human  Male  Middle Age  Powders  Support, Non-U.S.
       Gov't  Tablets  Therapeutic Equivalency  CLINICAL TRIAL  CONTROLLED
       CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

