Trial Outcomes & Findings for Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan. (NCT NCT06074016)
NCT ID: NCT06074016
Last Updated: 2026-05-05
Results Overview
To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Up to 24 hours.
Results posted on
2026-05-05
Participant Flow
From July 2023 to September 2023, participants were recruited from the Clinical Research Unit of Mar Hospital Research Institute database.
Participant milestones
| Measure |
Group 1 Intranasal-washout Period-oral
During Period 1, participants received a single dose of Zolmitriptan nasal spray (Zomig® 5 mg; Grünenthal Health). Following a 7-day washout period, participants received a single oral dose of Zolmitriptan Normon 5 mg orodispersible tablets (EFG; Laboratorios Normon) in Period 2.
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Group 2 Oral-washout Period- Intranasal
During Period 1, participants received a single oral dose of Zolmitriptan Normon 5 mg orodispersible tablets (EFG; Laboratorios Normon). Following a 7-day washout period, participants received a single dose of Zolmitriptan nasal spray (Zomig® 5 mg; Grünenthal Health) in Period 2.
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|---|---|---|
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Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=8 Participants
Healthy adult participants enrolled in this randomized crossover study evaluating oral and intranasal administration of Zolmitriptan.
|
|---|---|
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Age, Customized
|
24.7 Years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
22.2 kg/m^2
STANDARD_DEVIATION 2.5 • n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours.To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
|
Effects of Zolmitriptan on Heart Rate (HR).
|
64.4 lpm
Standard Deviation 13.9
|
71.7 lpm
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: Up to 24 hours.To assess the effects of Zolmitriptan on SBP; only results at 24 hours will be reported.
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
|
Effects of Zolmitriptan on Systolic Blood Pressure (SBP).
|
111.7 mmHg
Standard Deviation 9.6
|
111.7 mmHg
Standard Deviation 9.6
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PRIMARY outcome
Timeframe: Up to 24 hoursTo assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported.
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
|
Effects of Zolmitriptan Diastolic Blood Pressure (DBP)
|
63.4 mmHg
Standard Deviation 3.5
|
64.1 mmHg
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: up to 24 hoursArea under the curve from 0 time to the last measurable concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
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AUC(0-24h)
|
53.6 ng·h/mL
Standard Deviation 23.0
|
44.3 ng·h/mL
Standard Deviation 18.6
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PRIMARY outcome
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each DoseTime of maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
|
Tmax
|
4 min
Interval 2.0 to 8.0
|
4 min
Interval 2.0 to 12.0
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PRIMARY outcome
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each DoseThe mean maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
|
Cmax
|
6.82 ng/mL
Standard Deviation 2.97
|
5.71 ng/mL
Standard Deviation 2.61
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SECONDARY outcome
Timeframe: Up to 24 hours.AE was performed including number and percentage.
Outcome measures
| Measure |
Group: Intranasal
n=8 Participants
Results are presented by treatment received.
|
Group: Oral
n=8 Participants
Results are presented by treatment received.
|
|---|---|---|
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Adverse Effects (AE)
|
1 Participants
|
4 Participants
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Adverse Events
Group: Intranasal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group: Oral
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group: Intranasal
n=8 participants at risk
Results are presented by treatment received.
|
Group: Oral
n=8 participants at risk
Results are presented by treatment received.
|
|---|---|---|
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Nervous system disorders
Headache
|
12.5%
1/8 • From Day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
25.0%
2/8 • From Day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/8 • From Day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
12.5%
1/8 • From Day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
|
Gastrointestinal disorders
Gastroenteritis
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0.00%
0/8 • From Day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
12.5%
1/8 • From Day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
Additional Information
Rafael de la Torre Fornell/Ana M aldea Perona
Consorci PSMAR
Phone: (+34) 93 3160484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place