CompletedNCT00944645Updated Jun 19, 2015Results posted

MK0524A Bioequivalence Study (0524A-059)

A Phase 1 interventional study of niacin (+) laropiprant (Source 1) and Comparator: niacin (+) laropiprant (Source 2) in Dyslipidemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-19.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 188
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Conditions studied

Dyslipidemia

Browse trials for

Dyslipidemias 1,101

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's enrollment of 188 is above the median of 100 across 861 interventional studies indexed under Dyslipidemias.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject is in good health
Subject is willing to follow all study guidelines

Exclusion criteria

Exclusion Criteria:

Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 188 participants (actual)

Study arms

Active comparator
A
MK0524A Source 1 (Phase III manufacturing site)
Drug: niacin (+) laropiprant (Source 1)
Active comparator
B
MK0524A Source 2 (commercial manufacturing site)
Drug: Comparator: niacin (+) laropiprant (Source 2)

Interventions

Drugniacin (+) laropiprant (Source 1)
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
DrugComparator: niacin (+) laropiprant (Source 2)
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.

What researchers measure

Primary outcomes

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
Measure of rate of absorption of ER niacin
Time frame: Predose and up to 24 hours postdose
Total Amount of Urinary Excretion of Niacin and Its Metabolites
Measure of extent of absorption of ER niacin
Time frame: Predose and up to 96 hours postdose
Area Under Curve (AUC 0-infinity) of Laropiprant
Measure of extent of absorption of laropiprant
Time frame: Predose and up to 48 hours postdose
Maximum Concentration (Cmax) of Laropiprant
Measure of rate of absorption of laropiprant
Time frame: Predose and up to 48 hours postdose

Results

Posted Nov 25, 2009

Participant flow

Period 1

Participant flow — Period 1
Milestone	MK0524A Phase III Tablet Then MK0524A New Site Tablet	MK0524A New Site Tablet Then MK0524A Phase III Tablet
Started	94	94
Completed	94	94
Not completed	0	0

Period 2

Participant flow — Period 2
Milestone	MK0524A Phase III Tablet Then MK0524A New Site Tablet	MK0524A New Site Tablet Then MK0524A Phase III Tablet
Started	94	94
Completed	86	85
Not completed	8	9
Withdrew: Adverse event	1	0
Withdrew: Lost to follow-up	0	3
Withdrew: Withdrawal by subject	7	6

Outcome measures

PrimaryMaximum Plasma Concentration (Cmax) of Nicotinuric Acid

Measure of rate of absorption of ER niacin

Time frame:: Predose and up to 24 hours postdose
Reported as:: Median · ng/mL

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
ng/mL	MK0524A New Site Tablet	MK0524A Phase III Tablet
Maximum Plasma Concentration (Cmax) of Nicotinuric Acid	1190 (956 to 1610)	1260 (948 to 1660)

Statistical analysis

MK0524A New Site Tablet vs MK0524A Phase III Tablet · Geometric mean ratio: 0.98 · 90% CI 0.93 to 1.03

PrimaryTotal Amount of Urinary Excretion of Niacin and Its Metabolites

Measure of extent of absorption of ER niacin

Time frame:: Predose and up to 96 hours postdose
Reported as:: Median · micro mole

Total Amount of Urinary Excretion of Niacin and Its Metabolites
micro mole	MK0524A New Site Tablet	MK0524A Phase III Tablet
Total Amount of Urinary Excretion of Niacin and Its Metabolites	5280 ± 1894	5470 ± 1330

Statistical analysis

MK0524A New Site Tablet vs MK0524A Phase III Tablet · Geometric mean ratio: 0.94 · 90% CI 0.89 to 0.98

PrimaryArea Under Curve (AUC 0-infinity) of Laropiprant

Measure of extent of absorption of laropiprant

Time frame:: Predose and up to 48 hours postdose
Reported as:: Median · Micro Molar times Hour

Area Under Curve (AUC 0-infinity) of Laropiprant
Micro Molar times Hour	MK0524A New Site Tablet	MK0524A Phase III Tablet
Area Under Curve (AUC 0-infinity) of Laropiprant	6.36 ± 3.01	6.37 ± 2.66

Statistical analysis

MK0524A New Site Tablet vs MK0524A Phase III Tablet · Geometric mean ratio: 1.00 · 95% CI 0.95 to 1.05

PrimaryMaximum Concentration (Cmax) of Laropiprant

Measure of rate of absorption of laropiprant

Time frame:: Predose and up to 48 hours postdose
Reported as:: Median · micro Molar

Maximum Concentration (Cmax) of Laropiprant
micro Molar	MK0524A New Site Tablet	MK0524A Phase III Tablet
Maximum Concentration (Cmax) of Laropiprant	0.988 ± 0.563	0.975 ± 0.466

Statistical analysis

MK0524A New Site Tablet vs MK0524A Phase III Tablet · Geometric mean ratio: 1.02 · 95% CI 0.96 to 1.09

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MK0524A Phase III Tablet	—	0/188 (0%)	98/188 (52.1%)
MK0524A New Site Tablet	—	2/188 (1.1%)	100/188 (53.2%)

Most frequent serious events

Most frequent serious events
Event	MK0524A Phase III Tablet	MK0524A New Site Tablet
HematemesisGastrointestinal disorders	0/188	1/188
SyncopeNervous system disorders	0/188	1/188

Most frequent other events

Showing 10 of 73

Most frequent other events
Event	MK0524A Phase III Tablet	MK0524A New Site Tablet
FlushingVascular disorders	69/188	70/188
HeadacheNervous system disorders	15/188	20/188
PruritusSkin and subcutaneous tissue disorders	20/188	19/188
ParaesthesiaNervous system disorders	16/188	16/188
OverdoseInjury, poisoning and procedural complications	12/188	14/188
NauseaGastrointestinal disorders	13/188	11/188
DiarrhoeaGastrointestinal disorders	3/188	11/188
DizzinessNervous system disorders	10/188	7/188
VasodilatationVascular disorders	7/188	5/188
VomitingGastrointestinal disorders	4/188	6/188

Baseline characteristics

Age, Continuous
Age, Continuous(years)	All Participants
Mean	38.5 ± 1

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	92
Male	96

Height
Height(Centimeters)	All Participants
Mean	166.6 (140 to 190)

Weight
Weight(Kilograms)	All Participants
Mean	71.6 (48.4 to 101)

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006, a primary completion of Jan 2007 and a completion of Jan 2007. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2009, 2 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 21, 2009
First posted: Jul 23, 2009
Start: Oct 2006
Primary completionActual: Jan 2007
CompletionActual: Jan 2007
Results first posted: Nov 25, 2009
Last update: Jun 19, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00944645
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Jul 23, 2009
Start date: Oct 2006
Primary completion: Jan 2007
Completion: Jan 2007
Results posted: Nov 25, 2009
Last update: Jun 19, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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MK0524A Bioequivalence Study (0524A-059)

Study summary

Conditions studied

Browse trials for

In context

Dyslipidemias

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Timeline

Registry details

Key details

Study contacts

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria