Not applicable - Healthy Volunteer study
Conditions
Interventions
Product Name: Benicar
Pharmaceutical Form: Tablet
INN or Proposed INN: Olmesartan Medoxomil
CAS Number: 144689-63-4
Other descriptive name: OLMESARTAN MEDOXOMIL
Concentration unit: mg milligram(s)
Con
Sponsors
Sankyo Pharma Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Healthy adult male or female subjects, 18-45 years of age; b) Body Mass Index (BMI) between 19-32 kg/m2; c) All women must have a negative pregnancy test at Screening, at each check-in (Day -1) and at the end of study (Day 3). d) Women with: o all three of the following additional criteria: - Not pregnant. (Women of childbearing potential must have a negative serum pregnancy test at screening and check in). - Not breast-feeding. - Do not plan to become pregnant during the study. o AND women with one of the following three additional criteria: - Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum; - Have been postmenopausal for at least 2 years (or 1 year with a FSH level 40 mIU/mL). - Are of childbearing potential and were practicing one of the following methods of birth control at least 1 month prior to study start and will continue to practice throughout the study: • intrauterine device, • diaphragm plus spermicide; • female condom plus spermicide or partner condom plus spermicide. NOTE: Abstinence, partner's use of condoms without spermicide and partner's vasectomy were NOT acceptable methods of contraception. e) Negative drug and alcohol screening; f) Negative test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody; g) No clinically relevant abnormal finding at screening (physical exam, vital signs, ECGs and laboratory values) as deemed by the Principal Investigator; h) Gave voluntary written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Used any prescription drug within 7 days of study initiation or any non-prescription drug (including herbal supplements) within 7 days of study initiation; b) History or presence of significant cardiovascular disease; c) Sitting blood pressure less than 100/50 mmHg at screening or prior to dosing; d) Pulse lower than 40 b.p.m. at screening or prior to dosing; e) Treatment with any known drug metabolizing enzyme-altering drugs (inducers or inhibitors) within the 30 days prior to dosing; f) History of serum sickness or allergic reaction to any drug; g) History of drug abuse or alcohol addiction within the last 2 years; h) Donation of a unit of blood within the past 56 days prior to study initiation or plasma donation within 7 days of study initiation; i) Female subjects who are pregnant or lactating; j) Positive test for HIV antibody or hepatitis B (surface antigen) or C (antibody); k) Participated in another clinical trial within 28 days prior to the first dose; l) Consumed any alcoholic beverages and/or caffeine- or xanthine containing beverages within 48 hours prior to the first dose of each period; m) Consumed any food or beverages containing grapefruit from 10 days prior to the first dose of study medication through completion of the study; n) Employment by the research center; o) First degree familial relationship with another study participant, the Sponsor's associates, or clinical research center personnel; p) History of tobacco use for the past 12 months; q) Positive urine drug/alcohol screen at screening or check-in; r) PR interval is >260 msec at screening and prior to dosing; s) QTc interval >450 msec; t) Any clinical significant abnormality on electrocardiogram (ECG), as deemed by the Principal Investigator; u) Any screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator. Values for specific analytes noted below may not exceed the following limits: Hematology o Hemoglobin 1.25 x ULN o ALT (SGPT) > 1.25 x ULN o Alkaline Phosphatase > 1.25 x ULN o Total Bilirubin > 1.25 x ULN o BUN > 1.50 x ULN o Creatinine Kinase (CK) > 1.50 x ULN o Creatinine > 1.20 x ULN t) A clinically significant history or evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, oncologic, psychiatric disease or other medical condition as determined by screening history, physical examination, and ECG. Clinically significant is defined as that which may pose significant risk to the subject due to participation, or may confound the outcome/results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study was to determine if the compounded suspension formulation of olmesartan medoxomil (4 mg/mL × 10 mL, for a total dose of 40 mg) is bioequivalent to the marketed tablet formulation of Benicar® (1 × 40 mg tablet).;Secondary Objective: Not applicable;Primary end point(s): Standard pharmacokinetic parameters;Timepoint(s) of evaluation of this end point: 60 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety;Timepoint(s) of evaluation of this end point: 14d | — |
Countries
United States
Contacts
Public ContactClinical Trial Information
Daiichi Sankyo Development Ltd.
Outcome results
None listed