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Trial Outcomes & Findings for Triomune Bioequivalence With Innovators (NCT NCT01025830)

NCT ID: NCT01025830

Last Updated: 2010-01-05

Results Overview

Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Results posted on

2010-01-05

Participant Flow

Subjects were recruited from an ongoing cohort study in Kampala, Uganda. The first subject was recruited in Feb 2006.

Participants received a medical and laboratory examination before assignment. Subjects were excluded if they had active tuberculosis or were anemic. 22 participants were recruited; 22 were screened,2 were excluded (1 did not meet inclusion criteria and 1 refused participation).

Participant milestones

Participant milestones
Measure
Generic (Triomune) to Brand (Zerit/Epivir/Viramune)
Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
Brand (Zerit/Epivir/Viramune) to Generic (Triomune)
started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)
Generic (Tr) First Then Brand (Ze/Ep/Vi)
STARTED
8
12
Generic (Tr) First Then Brand (Ze/Ep/Vi)
COMPLETED
8
12
Generic (Tr) First Then Brand (Ze/Ep/Vi)
NOT COMPLETED
0
0
Washout Period of 30 Days
STARTED
8
12
Washout Period of 30 Days
COMPLETED
8
12
Washout Period of 30 Days
NOT COMPLETED
0
0
Brand (Ze/Ep/Vi) First Then Generic (Tr)
STARTED
8
12
Brand (Ze/Ep/Vi) First Then Generic (Tr)
COMPLETED
8
12
Brand (Ze/Ep/Vi) First Then Generic (Tr)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Triomune Bioequivalence With Innovators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=20 Participants
Includes groups randomized to receive generic formulation and brand formulation
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
37.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Body Mass Index
25.1 kg/m2
STANDARD_DEVIATION 3.4 • n=5 Participants
Weight
68.3 kg
STANDARD_DEVIATION 6.6 • n=5 Participants

PRIMARY outcome

Timeframe: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Population: Analyzed population consists only of participants who had sufficient plasma samples for analysis.Intent to treat analysis was used. Separate analyses provided for each drug. Results of such a study are not combined.

Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed

Outcome measures

Outcome measures
Measure
Generic Stavudine
n=7 Participants
period when subjects were on generic stavudine
Brand Stavudine
n=11 Participants
period when subjects were on brand stavudine
Generic Nevirapine
n=7 Participants
period when subjects were on generic nevirapine
Brand Nevirapine
n=11 Participants
Period when subjects were on brand nevirapine
Generic Lamivudine
n=7 Participants
period when subjects were on generic lamivudine
Brand Lamivudine
n=11 Participants
Period when subjects were on brand lamivudine
Area Under the Concentration-Time Curve(AUC)
3.6 hour*milligram/liter
Standard Deviation 2.4
3.4 hour*milligram/liter
Standard Deviation 3.9
85.8 hour*milligram/liter
Standard Deviation 35.2
79.2 hour*milligram/liter
Standard Deviation 45.7
5.2 hour*milligram/liter
Standard Deviation 2.5
6.4 hour*milligram/liter
Standard Deviation 4.9

SECONDARY outcome

Timeframe: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Population: Intention to treat analysis used including only participants with sufficient plasma samples for analysis. Separate analyses are given for each drug. Results for this kind of study are not combined.

Maximum concentration of drug in plasma that was attained post dosing

Outcome measures

Outcome measures
Measure
Generic Stavudine
n=7 Participants
period when subjects were on generic stavudine
Brand Stavudine
n=11 Participants
period when subjects were on brand stavudine
Generic Nevirapine
n=7 Participants
period when subjects were on generic nevirapine
Brand Nevirapine
n=11 Participants
Period when subjects were on brand nevirapine
Generic Lamivudine
n=7 Participants
period when subjects were on generic lamivudine
Brand Lamivudine
n=11 Participants
Period when subjects were on brand lamivudine
Maximum Plasma Concentration of Drug
1.6 milligram/liter
Standard Deviation 1.1
1.3 milligram/liter
Standard Deviation 2.0
8.8 milligram/liter
Standard Deviation 3.1
8.4 milligram/liter
Standard Deviation 5.5
1.0 milligram/liter
Standard Deviation 0.5
1.3 milligram/liter
Standard Deviation 1.4

Adverse Events

Entire Study Population

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Generic to Brand

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Brand to Generic

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

Jayne Byakika Tusiime

University of California Berkeley

Phone: 1 510 219 7567

Results disclosure agreements

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