Healthy
Conditions
Keywords
Bioequivalence, Healthy Subjects
Brief summary
This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd. with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 180 mg tablet) in healthy adult volunteers under fed conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Interventions
1 x 180 mg
1 x 180 mg
Sponsors
Teva Pharmaceuticals USA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* All volunteers selected for this study will be healthy, non-smoking men and women 18 to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index (BMI) is less that or equal to 30. * If female and : * Of child bearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or * Is postmenopausal for at least 1 year; or * Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Exclusion criteria
* Volunteers with a recent history of drug or alcohol addiction or abuse. * Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators). * Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant. * Volunteers demonstration a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen. * Volunteers demonstrating a positive drug abuse screen when screened for this study. * Female volunteers who are currently breast feeding. * Female volunteers who are demonstrating a positive pregnancy screen. * Volunteers with a history of allergic response(s) to fexofenadine or related drugs. * Volunteers with a history of clinically significant allergies including drug allergies. * Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators). * Volunteers who currently use or reports using tobacco or nicotine-containing products within 90 days prior to Period I dosing. * Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing. * Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will by advised not to donate blood for four weeks after completing the study. * Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study. * Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing. * Volunteers who report taking any prescription medication in the 14 days prior to Period I dosing, with the exception of topical products without systemic absorption. * Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing. * Volunteers who report an intolerance of direct venipuncture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax = Maximum Observed Concentration. | Blood samples collected over a 48 hour period. | Bioequivalence based on Cmax. |
| AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) | Blood samples collected over a 48 hour period. | Bioequivalence based on AUC0-t. |
| AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. | Blood samples collected over a 48 hour period. | Bioequivalence based on AUC0-inf. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fexofenadine Hydrochloride First 180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period. | 12 |
| Allegra® First 180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Fexofenadine Hydrochloride First | Allegra® First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized American Indian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 12 participants | 11 participants | 23 participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Outcome results
Primary
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Bioequivalence based on AUC0-inf.
Time frame: Blood samples collected over a 48 hour period.
Population: All participants that completed the study had their samples analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fexofenadine Hydrochloride | AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. | 2061.26 ng*h/mL | Standard Deviation 627.94 |
| Allegra® | AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. | 2324.97 ng*h/mL | Standard Deviation 718.31 |
Primary
AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
Bioequivalence based on AUC0-t.
Time frame: Blood samples collected over a 48 hour period.
Population: All participants that completed the study had their samples analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fexofenadine Hydrochloride | AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) | 1894.48 ng*h/mL | Standard Deviation 562 |
| Allegra® | AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) | 2159.85 ng*h/mL | Standard Deviation 671.03 |
Primary
Cmax = Maximum Observed Concentration.
Bioequivalence based on Cmax.
Time frame: Blood samples collected over a 48 hour period.
Population: All participants that completed the study had their samples analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fexofenadine Hydrochloride | Cmax = Maximum Observed Concentration. | 311.45 ng/mL | Standard Deviation 99.83 |
| Allegra® | Cmax = Maximum Observed Concentration. | 382.48 ng/mL | Standard Deviation 119.07 |