Trial Outcomes & Findings for A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED) (NCT NCT00971633)

NCT ID: NCT00971633

Last Updated: 2016-09-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
• Results posted on: 2016-09-14

Participant Flow

Participant milestones

Measure	OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally	U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally.	U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally	OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally	U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally	U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally
Period 1 STARTED	2	2	2	2	2	2
Period 1 COMPLETED	2	2	2	2	2	2
Period 1 NOT COMPLETED	0	0	0	0	0	0
Period 2 STARTED	2	2	2	2	2	2
Period 2 COMPLETED	2	2	2	2	2	2
Period 2 NOT COMPLETED	0	0	0	0	0	0
Period 3 STARTED	2	2	2	2	2	2
Period 3 COMPLETED	2	2	2	2	2	2
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

Baseline characteristics by cohort

Measure	All Participants n=12 Participants All randomized participants
Age, Continuous	31.7 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Weight	78.5 kilograms n=5 Participants
Height	171.1 centimeters n=5 Participants

PRIMARY outcome

Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose

Population: All study participants (N=12)

Outcome measures

Measure	Treatment OE U.K. Tablet n=12 Participants Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally	Treatment U.K. Tablet n=12 Participants Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally	Treatment U.S. Tablet n=12 Participants Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron	644 nM*hr Standard Deviation 240	712 nM*hr Standard Deviation 233	649 nM*hr Standard Deviation 255

PRIMARY outcome

Timeframe: 24 hours post dose

Population: All study participants (N=12)

Outcome measures

Measure	Treatment OE U.K. Tablet n=12 Participants Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally	Treatment U.K. Tablet n=12 Participants Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally	Treatment U.S. Tablet n=12 Participants Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
Maximum Plasma Concentration (Cmax) of Ondansetron	82 nM Standard Deviation 18	93 nM Standard Deviation 16	86 nM Standard Deviation 20

Adverse Events

Treatment OE U.K. Tablet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment U.K. Tablet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment U.S. Tablet

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment OE U.K. Tablet n=12 participants at risk Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally	Treatment U.K. Tablet n=12 participants at risk Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally	Treatment U.S. Tablet n=12 participants at risk Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
Infections and infestations Nasopharyngitis	0.00% 0/12 • Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.	0.00% 0/12 • Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.	8.3% 1/12 • Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.	0.00% 0/12 • Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.	8.3% 1/12 • Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.

Additional Information

Executive Vice President, Clinical and Quantitative Sciences

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER