Trial Outcomes & Findings for The Bioequivalence of Atripla in an Oral Liquid Formulation Compared With the Tablet Formulation in Healthy Volunteers (NCT NCT00862823)

NCT ID: NCT00862823

Last Updated: 2012-09-14

Results Overview

The area under the concentration time curve for tenofovir, emtricitabine and efavirenz

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: 17 days
• Results posted on: 2012-09-14

Participant Flow

Healthy volunteers recruited in Birmingham, AL from March 2009 and August 2009

Participant milestones

Measure	Tablet First, Then Liquid Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period	Liquid First, Then Tablet Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
First Intervention STARTED	6	10
First Intervention COMPLETED	5	9
First Intervention NOT COMPLETED	1	1
Washout Period of 2 Weeks STARTED	5	9
Washout Period of 2 Weeks COMPLETED	5	9
Washout Period of 2 Weeks NOT COMPLETED	0	0
Second Intervention STARTED	5	9
Second Intervention COMPLETED	5	9
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Tablet First, Then Liquid Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period	Liquid First, Then Tablet Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
First Intervention Withdrawal by Subject	1	1

Baseline Characteristics

The Bioequivalence of Atripla in an Oral Liquid Formulation Compared With the Tablet Formulation in Healthy Volunteers

Baseline characteristics by cohort

Measure	Entire Study Population n=16 Participants Includes groups randomized to receive tablet first and liquid first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	33.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 17 days

Population: US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.

The area under the concentration time curve for tenofovir, emtricitabine and efavirenz

Outcome measures

Measure	Atripla Tablet n=14 Participants Includes groups randomized to receive tablet first and liquid first	Atripla Liquid n=14 Participants Includes groups randomized to receive tablet first and liquid first
Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz Efavirenz AUC	58.7 mg*hr/mL Geometric Coefficient of Variation 57.5	56.7 mg*hr/mL Geometric Coefficient of Variation 80
Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz Emtricitabine AUC	10.9 mg*hr/mL Geometric Coefficient of Variation 24.7	10.8 mg*hr/mL Geometric Coefficient of Variation 15.9
Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz Tenofovir AUC	1.8 mg*hr/mL Geometric Coefficient of Variation 29.2	2.2 mg*hr/mL Geometric Coefficient of Variation 36.3

PRIMARY outcome

Timeframe: 17 days

Population: US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.

The maximum concentration for tenofovir, emtricitabine and efavirenz

Outcome measures

Measure	Atripla Tablet n=14 Participants Includes groups randomized to receive tablet first and liquid first	Atripla Liquid n=14 Participants Includes groups randomized to receive tablet first and liquid first
Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz Efavirenz Cmax	1.5 mg/L Geometric Coefficient of Variation 39	1.3 mg/L Geometric Coefficient of Variation 28.8
Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz Emtricitabine Cmax	1.8 mg/L Geometric Coefficient of Variation 32.3	2.1 mg/L Geometric Coefficient of Variation 21
Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz Tenofovir Cmax	0.3 mg/L Geometric Coefficient of Variation 27.7	0.2 mg/L Geometric Coefficient of Variation 47.8

Adverse Events

Entire Study Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer King

University of Alabama at Birmingham

Phone: 205-934-2696

Email: jenking@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place