Moore KH, Lloyd PP, Duncan B, O'Mara M, Culverhouse E, Kearney M, Morris D, Kunka RL, Shaw S; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 5th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 5th 1998 Chic Ill. 1998 Feb 1-5; 5th: 205 (abstract no. 671).
Glaxo Wellcome Inc., Research Triangle Park, NC.
Combivir is a tablet formulation combining lamivudine (3TC) 150mg and zidovudine (ZDV) 300mg. Combivir will permit the reduction in the daily "pill" burden for many HIV patients. The bioequivalence of Combivir was evaluated relative to coadministration of the marketed Epivir (3TC 150mg) and Retrovir (ZDV 300mg) tablets. The effect of food on Combivir bioavailability was also examined in this randomized, open-label, three-way crossover study conducted in healthy male (n=12) and female (n=12) subjects. Doses were administered orally after an 8h fast or after a standardized meal (fat 67g, protein 33g, and carbohydrate 58g). Serial blood samples for 3TC and ZDV determination were collected over 24h. (Table: see text) Combivir was bioequivalent to coadministration of the Epivir and Retrovir tablets when administered under fasted conditions (90% CI of the GLS mean ratios of AUC(last), AUC(infinity), and C(max) for 3TC and ZDV were within the range of 0.80 - 1.25). The effect of food on Combivir bioavailability was consistent with previous observations with 3TC and ZDV formulations and dosage strengths showing a reduction in rate but not the extent of absorption. Thus, Combivir may be administered with or without food. All formulations were well tolerated under fasted and/or fed conditions.
Publication Types:
Keywords:
- Absorption
- Acquired Immunodeficiency Syndrome
- Area Under Curve
- Biological Availability
- Combivir
- Cross-Over Studies
- Drug Combinations
- Fasting
- Female
- Food
- Food-Drug Interactions
- HIV Infections
- Humans
- Lamivudine
- Male
- Therapeutic Equivalency
- Zidovudine
Other ID:
UI: 102236253
From Meeting Abstracts