Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Mary F. Paine, PhD, RPh, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01526213
First received: January 31, 2012
Last updated: December 29, 2012
Last verified: December 2012
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Results First Received: March 3, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label |
| Condition: |
Food-drug Interaction |
| Intervention: |
Drug: Fexofenadine |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Screening began in September 2009. Potential eligible subjects presented for a screening visit at the UNC Clinical and Translational Research Center (CTRC) within 1 month prior to the first day of the study. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No significant events/approaches for overall study following participant enrollment but prior to group assignment. 18 subjects recruited and screened. No exclusions. |
Reporting Groups
| Description | |
|---|---|
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period. |
| Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period. |
| Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period. |
| Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period. |
| Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period. |
| Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period. |
Participant Flow for 5 periods
Period 1: Period 1 (5 Days)
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | |
|---|---|---|---|---|---|---|
| STARTED | 3 [1] | 3 [1] | 3 [1] | 3 [1] | 3 [1] | 3 [2] |
| COMPLETED | 3 [3] | 3 [3] | 3 [3] | 3 [3] | 3 [3] | 3 [3] |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| [1] | 3-way crossover study. Each subject was assigned to one of six sequences. |
|---|---|
| [2] | 3-way crossover study. Each subject was assigned to (and completed) one of six sequences. |
| [3] | Each subject served as his/her own control and completed assigned sequence. |
Period 2: Washout 1 (10 Days)
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | |
|---|---|---|---|---|---|---|
| STARTED | 3 | 3 | 3 | 3 | 3 | 3 |
| COMPLETED | 3 | 3 | 3 | 3 | 3 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period 3: Period 2 (5 Days)
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | |
|---|---|---|---|---|---|---|
| STARTED | 3 [1] | 3 [1] | 3 [1] | 3 [1] | 3 [1] | 3 [1] |
| COMPLETED | 3 [2] | 3 [2] | 3 [3] | 3 [3] | 3 [3] | 3 [3] |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| [1] | 3-way crossover study. Each subject was assigned to one of six sequences. |
|---|---|
| [2] | Each subject served as his/her own control and completed assigned sequence. |
| [3] | 3-way crossover study. Each subject was his/her own control and underwent all 3 treatments. |
Period 4: Washout 2 (10 Days)
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | |
|---|---|---|---|---|---|---|
| STARTED | 3 | 3 | 3 | 3 | 3 | 3 |
| COMPLETED | 3 | 3 | 3 | 3 | 3 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period 5: Period 3 (5 Days)
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | |
|---|---|---|---|---|---|---|
| STARTED | 3 [1] | 3 [1] | 3 [1] | 3 [1] | 3 [1] | 3 [1] |
| COMPLETED | 3 [2] | 3 [2] | 3 [2] | 3 [2] | 3 [2] | 3 [2] |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| [1] | 3-way crossover study. Each subject was assigned to one of six sequences. |
|---|---|
| [2] | Each subject served as his/her own control and completed assigned sequence. |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period. |
| Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period. |
| Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period. |
| Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period. |
| Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period. |
| Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period. |
| Total | Total of all reporting groups |
Baseline Measures
| Sequence 1: Water, GFJ, Furanocoumarin-free GFJ | Sequence 2: Water, Furanocoumarin-free GFJ, GFJ | Sequence 3: GFJ, Furanocoumarin-free GFJ, Water | Sequence 4: GFJ, Water, Furanocoumarin-free GFJ | Sequence 5: Furanocoumarin-free GFJ, GFJ, Water | Sequence 6: Furanocoumarin-free GFJ, Water, GFJ | Total | |
|---|---|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
3 | 3 | 3 | 3 | 3 | 3 | 18 |
|
Age
[units: years] Mean ± Standard Deviation |
|||||||
| Mean | 26 ± 1.0 | 34 ± 17 | 51 ± 11 | 39 ± 11 | 33 ± 9.1 | 30 ± 7.5 | 36 ± 12 |
|
Gender
[units: participants] |
|||||||
| Female | 2 | 1 | 0 | 2 | 1 | 3 | 9 |
| Male | 1 | 2 | 3 | 1 | 2 | 0 | 9 |
|
Region of Enrollment
[units: participants] |
|||||||
| United States | 3 | 3 | 3 | 3 | 3 | 3 | 18 |
Outcome Measures
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Mary F. Paine, RPh, PhD
Organization: UNC-Chapel Hill
phone: 919-966-9984
e-mail: mpaine@unc.edu
Organization: UNC-Chapel Hill
phone: 919-966-9984
e-mail: mpaine@unc.edu
No publications provided
| Responsible Party: | Mary F. Paine, PhD, RPh, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01526213 History of Changes |
| Other Study ID Numbers: | IRB 09-0788 |
| Study First Received: | January 31, 2012 |
| Results First Received: | March 3, 2012 |
| Last Updated: | December 29, 2012 |
| Health Authority: | United States: Institutional Review Board |