Trial Outcomes & Findings for Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers (NCT NCT02036775)
NCT ID: NCT02036775
Last Updated: 2015-05-13
Results Overview
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Results posted on
2015-05-13
Participant Flow
A randomised, open-label, three period, crossover study. Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment.
Participant milestones
| Measure |
Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg
Patients were administered three treatments in the following order:
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg
Patients were administered three treatments in the following order:
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg
Patients were administered three treatments in the following order:
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg
Patients were administered three treatments in the following order:
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg
Patients were administered three treatments in the following order:
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg
Patients were administered three treatments in the following order:
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (6 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 1 (6 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 1 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (6 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 2 (6 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 2 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3 (6 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 3 (6 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 3 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg
Patients were administered three treatments in the following order:
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg
Patients were administered three treatments in the following order:
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg
Patients were administered three treatments in the following order:
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg
Patients were administered three treatments in the following order:
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg
Patients were administered three treatments in the following order:
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg
Patients were administered three treatments in the following order:
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|---|---|---|
|
Treatment Period 2 (6 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Study Overall
n=24 Participants
A randomised, open-label, three period, crossover study. The three treatments administered were:
* One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
* One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
* One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment.
|
|---|---|
|
Age, Continuous
|
25.04 years
STANDARD_DEVIATION 6.423 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: Pharmacokinetic (PK) set relative bioavailability set (PK-BA set) which includes all subjects in the treated set who completed 3 periods and for whom the PK profiles in 3 periods could be adequately characterized in respect to at least 1 of the PK parameters of primary interest without important protocol violations relevant to the evaluation of PK.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State
|
1182.084 ng*h/mL
Geometric Coefficient of Variation 28.859
|
1110.095 ng*h/mL
Geometric Coefficient of Variation 28.292
|
1070.909 ng*h/mL
Geometric Coefficient of Variation 32.259
|
PRIMARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Maximum Measured Concentration of the Analyte in Plasma at Steady State
|
73.510 ng/mL
Geometric Coefficient of Variation 26.927
|
90.755 ng/mL
Geometric Coefficient of Variation 34.426
|
87.289 ng/mL
Geometric Coefficient of Variation 34.426
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg
|
945.667 ng*h/mL
Geometric Coefficient of Variation 28.859
|
1110.095 ng*h/mL
Geometric Coefficient of Variation 28.292
|
1070.909 ng*h/mL
Geometric Coefficient of Variation 32.259
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)
|
0.062 1/h
Geometric Coefficient of Variation 13.477
|
0.082 1/h
Geometric Coefficient of Variation 14.568
|
0.082 1/h
Geometric Coefficient of Variation 13.477
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgSteady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval
|
24.891 ng/mL
Geometric Coefficient of Variation 39.355
|
22.740 ng/mL
Geometric Coefficient of Variation 37.260
|
21.523 ng/mL
Geometric Coefficient of Variation 40.803
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State
|
49.254 ng/mL
Geometric Coefficient of Variation 28.859
|
46.254 ng/mL
Geometric Coefficient of Variation 28.292
|
44.621 ng/mL
Geometric Coefficient of Variation 32.259
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24.
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State
Tmax,ss,0-12h (N=0, 23, 23)
|
NA hours
This was not determined for Lasolvan 75mg as dosing was once daily.
|
1.00 hours
Interval 0.75 to 3.0
|
2.00 hours
Interval 0.75 to 3.0
|
|
Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State
Tmax,ss,12-24h (N=0, 23, 23)
|
NA hours
This was not determined for Lasolvan 75mg as dosing was once daily.
|
13.50 hours
Interval 12.75 to 16.0
|
14.00 hours
Interval 13.0 to 16.0
|
|
Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State
Tmax,ss,h (N=23, 0, 0)
|
6.00 hours
Interval 2.0 to 12.0
|
NA hours
Tmax,ss was determined as tmax,ss 0-12 and tmax,ss 12-24 for Lasolvan 60mg as dosing was twice daily.
|
NA hours
Tmax,ss was determined as tmax,ss 0-12 and tmax,ss 12-24 for Lasolvan 30mg as dosing was twice daily
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma
|
0.994 ng/mL
Standard Deviation 0.278
|
1.482 ng/mL
Standard Deviation 0.322
|
1.483 ng/mL
Standard Deviation 0.318
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)\*100)
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Peak-trough Swing
|
205.054 percentage of ng/mL
Standard Deviation 82.703
|
313.106 percentage of ng/mL
Standard Deviation 113.101
|
322.120 percentage of ng/mL
Standard Deviation 135.222
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Time period when the concentration of the analyte exceeds Cav ss (T (C\>Cav ss))
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Time Period When Concentration of the Analyte Exceeds Cav ss
|
10.500 hours
Interval 8.0 to 12.5
|
8.500 hours
Interval 5.75 to 10.0
|
7.750 hours
Interval 5.25 to 10.75
|
SECONDARY outcome
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mgPopulation: PK-BA set
Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C\>75% Cmax ss))
Outcome measures
| Measure |
Lasolvan 75mg
n=23 Participants
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
|
Lasolvan 60mg
n=23 Participants
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
|
Lasolvan 30mg
n=23 Participants
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
|
|---|---|---|---|
|
Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss
|
9.00 hours
Interval 0.0 to 13.0
|
2.25 hours
Interval 0.5 to 5.75
|
2.00 hours
Interval 0.5 to 5.25
|
Adverse Events
Lasolvan 75mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lasolvan 60mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lasolvan 30mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER