Trial Outcomes & Findings for Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106) (NCT NCT00972595)
NCT ID: NCT00972595
Last Updated: 2015-08-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose
Results posted on
2015-08-19
Participant Flow
Participant milestones
| Measure |
OE U.K. Tablet Then U.K. Tablet
Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. 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
|
U.K. Tablet Then OE U.K. Tablet
U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
|
|---|---|---|
|
Period 1
STARTED
|
23
|
22
|
|
Period 1
COMPLETED
|
22
|
22
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
22
|
22
|
|
Period 2
COMPLETED
|
22
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
OE U.K. Tablet Then U.K. Tablet
Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. 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
|
U.K. Tablet Then OE U.K. Tablet
U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
Baseline Characteristics
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Baseline characteristics by cohort
| Measure |
All Participants
n=45 Participants
All Randomized Participants
|
|---|---|
|
Age, Continuous
|
34 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Height
|
170.8 Centimeters
n=5 Participants
|
|
Weight
|
72.0 Killograms
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 postdosePopulation: All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.
Outcome measures
| Measure |
OE U.K. Tablet
n=44 Participants
Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
|
U.K. Tablet
n=44 Participants
Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
|
|---|---|---|
|
Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
|
257.8 ng*hr/mL
Standard Deviation 106.8
|
262.6 ng*hr/mL
Standard Deviation 105.6
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.
Outcome measures
| Measure |
OE U.K. Tablet
n=44 Participants
Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
|
U.K. Tablet
n=44 Participants
Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) for Ondansetron
|
41.3 ng/mL
Standard Deviation 13.7
|
41.8 ng/mL
Standard Deviation 13.6
|
Adverse Events
OE U.K. Tablet Then U.K. Tablet
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
U.K. Tablet Then OE U.K. Tablet
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OE U.K. Tablet Then U.K. Tablet
n=45 participants at risk；n=23 participants at risk
Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. 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
|
U.K. Tablet Then OE U.K. Tablet
n=44 participants at risk；n=22 participants at risk
U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Aborted Pregnancy
|
0.00%
0/23 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
4.5%
1/22 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
Other adverse events
| Measure |
OE U.K. Tablet Then U.K. Tablet
n=45 participants at risk；n=23 participants at risk
Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. 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
|
U.K. Tablet Then OE U.K. Tablet
n=44 participants at risk；n=22 participants at risk
U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
2.3%
1/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
General disorders
Chills
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
General disorders
Pain
|
0.00%
0/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
2.3%
1/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Infections and infestations
Ear Infection
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
2.3%
1/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
2.3%
1/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Nervous system disorders
Headache
|
15.6%
7/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
11.4%
5/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Nervous system disorders
Sinus Headache
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
2.3%
1/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
0.00%
0/44 • Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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