Trial Outcomes & Findings for Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults (NCT NCT00966641)

Results Overview

Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.

Results posted on

2015-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	PL3100 First, Then Naproxen First Intervention Period: PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen) (after 7-14 day washout period) Second Intervention Period: Naproxen: Single orally administered dose of 500 mg naproxen	Naproxen First, Then PL3100 First Intervention Period: Naproxen: Single orally administered dose of 500 mg naproxen (after 7-14 day washout period) Second Intervention Period: PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)
First Intervention STARTED	17	17
First Intervention COMPLETED	17	17
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	17	17
Second Intervention COMPLETED	17	17
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=34 Participants All study participants who were enrolled in the study.
Age, Continuous	38.2 years STANDARD_DEVIATION 12.43 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.

Population: Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.

Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.

Outcome measures

Outcome measures
Measure	PL 3100 n=28 Participants Active experimental drug PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)	Naproxen n=28 Participants Active comparator Naproxen: Single orally administered dose of 500 mg naproxen
Area Under the Curve of Plasma Naproxen From 0 to t	67763.0 min×μg/mL Interval 38832.6 to 100019.6	69427.9 min×μg/mL Interval 39529.0 to 93963.1

Adverse Events

PL 3100

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Naproxen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PL 3100 n=34 participants at risk Active experimental drug PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)	Naproxen n=34 participants at risk Active comparator Naproxen: Single orally administered dose of 500 mg naproxen
Blood and lymphatic system disorders Elevated Partial Thromboplastin Time	2.9% 1/34 • Number of events 1	0.00% 0/34

Additional Information

Ronald Zimmerman

PLx Pharma

Phone: 1-713-842-1249

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Standard Confidentiality Agreement
Publication restrictions are in place

Restriction type: OTHER