Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 mg

Who may be able to join

• Age: 18 years and older
• Sex: Male and/or non-pregnant, non-lactating female a. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, serum may be collected for the HCG pregnancy test within 48 hours prior to dosing for each study period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study. b. Women must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following: 1) intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or 2) barrier methods containing or used in conjunction with a spermicidal agent, or 3) surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year. c. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history: 1) postmenopausal with an absence of menses for at least one (1) year, or 2) bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or 3) total hysterectomy d. During the course of the study, from study screen until study exit, all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This requirement should be documented in the informed consent form.
• At least 60 kg (132 lbs.) for men and 48 kg (106 lbs.) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
• All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.